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Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation (JANUS)

Primary Purpose

Locally Advanced Rectal Carcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
5-fluorouracil
Leucovorin calcium
Irinotecan
Oxaliplatin
Long Course Chemoradiotherapy
Computed Tomography
Magnetic Resonance Imaging
Sigmoidoscopy
biopsy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis Tumor site: Rectum; =< 12cm from the anal verge No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for >= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for >= 6 months after the last treatment Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (or Karnofsky >= 60%) Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 50 mL/min ^3 Total bilirubin =< 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) No upper rectal tumors (distal margin of tumor > 12 cm from the anal verge) No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis No known mismatch repair deficient rectal adenocarcinoma Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Sites / Locations

  • Mission Hope Medical Oncology - Arroyo Grande
  • City of Hope Comprehensive Cancer Center
  • Washington Hospital
  • City of Hope at Irvine Lennar
  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center
  • Saint Joseph Hospital - Orange
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
  • University of California Davis Comprehensive Cancer Center
  • Salinas Valley Memorial
  • Mission Hope Medical Oncology - Santa Maria
  • City of Hope South Pasadena
  • City of Hope South Bay
  • City of Hope Upland
  • Penrose-Saint Francis Healthcare
  • Saint Francis Cancer Center
  • Hartford Hospital
  • Midstate Medical Center
  • The Hospital of Central Connecticut
  • Beebe South Coastal Health Campus
  • Beebe Medical Center
  • Delaware Clinical and Laboratory Physicians PA
  • Helen F Graham Cancer Center
  • Medical Oncology Hematology Consultants PA
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • MedStar Washington Hospital Center
  • Morton Plant Hospital
  • University of Florida Health Science Center - Gainesville
  • Saint Joseph's Hospital-North
  • AdventHealth Orlando
  • Saint Anthony's Hospital Cancer Care Center
  • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Saint Luke's Cancer Institute - Boise
  • Saint Luke's Cancer Institute - Fruitland
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Saint Luke's Cancer Institute - Twin Falls
  • Advocate Good Shepherd Hospital
  • Centralia Oncology Clinic
  • Northwestern University
  • John H Stroger Jr Hospital of Cook County
  • University of Chicago Comprehensive Cancer Center
  • Advocate Illinois Masonic Medical Center
  • AMG Crystal Lake - Oncology
  • Carle at The Riverfront
  • Cancer Care Specialists of Illinois - Decatur
  • Decatur Memorial Hospital
  • Northwestern Medicine Cancer Center Kishwaukee
  • Advocate Good Samaritan Hospital
  • Carle Physician Group-Effingham
  • Crossroads Cancer Center
  • Elmhurst Memorial Hospital
  • Northwestern Medicine Cancer Center Delnor
  • Advocate South Suburban Hospital
  • Northwestern Medicine Lake Forest Hospital
  • AMG Libertyville - Oncology
  • Condell Memorial Hospital
  • Carle Physician Group-Mattoon/Charleston
  • Edward Hospital/Cancer Center
  • UC Comprehensive Cancer Center at Silver Cross
  • Cancer Care Center of O'Fallon
  • Advocate Christ Medical Center
  • University of Chicago Medicine-Orland Park
  • Advocate Lutheran General Hospital
  • Southern Illinois University School of Medicine
  • Springfield Clinic
  • Memorial Medical Center
  • Carle Cancer Center
  • Northwestern Medicine Cancer Center Warrenville
  • Parkview Regional Medical Center
  • Mercy Hospital
  • Oncology Associates at Mercy Medical Center
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Cancer Center-West Lakes
  • Greater Regional Medical Center
  • Mercy Medical Center - Des Moines
  • Mission Cancer and Blood - Laurel
  • Mercy Medical Center-West Lakes
  • Ochsner Medical Center Jefferson
  • Lafayette Family Cancer Center-EMMC
  • Sinai Hospital of Baltimore
  • Boston Medical Center
  • Saint Joseph Mercy Hospital
  • Saint Joseph Mercy Brighton
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton
  • Saint Joseph Mercy Canton
  • Trinity Health IHA Medical Group Hematology Oncology - Canton
  • Caro Cancer Center
  • Saint Joseph Mercy Chelsea
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  • Beaumont Hospital - Dearborn
  • Beaumont Hospital - Farmington Hills
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Sparrow Hospital
  • Trinity Health Saint Mary Mercy Livonia Hospital
  • Saint Mary's Oncology/Hematology Associates of Marlette
  • 21st Century Oncology-Pontiac
  • Saint Joseph Mercy Oakland
  • William Beaumont Hospital-Royal Oak
  • Ascension Saint Mary's Hospital
  • Oncology Hematology Associates of Saginaw Valley PC
  • Ascension Saint Joseph Hospital
  • William Beaumont Hospital - Troy
  • Saint Mary's Oncology/Hematology Associates of West Branch
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  • Sanford Joe Lueken Cancer Center
  • Minnesota Oncology - Burnsville
  • Minnesota Oncology Hematology PA-Maplewood
  • Abbott-Northwestern Hospital
  • United Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Baptist Memorial Hospital and Cancer Center-Golden Triangle
  • Baptist Cancer Center-Grenada
  • Baptist Memorial Hospital and Cancer Center-Union County
  • Baptist Memorial Hospital and Cancer Center-Oxford
  • Baptist Memorial Hospital and Cancer Center-Desoto
  • Saint Francis Medical Center
  • Delbert Day Cancer Institute at PCRMC
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Mercy Hospital Saint Louis
  • CoxHealth South Hospital
  • OptumCare Cancer Care at Seven Hills
  • OptumCare Cancer Care at Charleston
  • Radiation Oncology Centers of Nevada Central
  • Radiation Oncology Centers of Nevada Southeast
  • OptumCare Cancer Care at MountainView
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Comprehensive Cancer Centers of Nevada
  • OptumCare Cancer Care at Fort Apache
  • Renown Regional Medical Center
  • New Hampshire Oncology Hematology PA-Concord
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  • The Dana-Farber Cancer Institute at Londonderry
  • Solinsky Center for Cancer Care
  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Holy Name Hospital
  • Montefiore Medical Center-Einstein Campus
  • Montefiore Medical Center-Weiler Hospital
  • Montefiore Medical Center - Moses Campus
  • Roswell Park Cancer Institute
  • Memorial Sloan Kettering Commack
  • Northwell Health Cancer Institute at Huntington
  • Memorial Sloan Kettering Westchester
  • Northwell Health/Center for Advanced Medicine
  • NYU Winthrop Hospital
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Mount Sinai West
  • Lenox Hill Hospital
  • Mount Sinai Hospital
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester
  • Memorial Sloan Kettering Nassau
  • Wilmot Cancer Institute at Webster
  • Duke Cancer Institute Cary
  • UNC Lineberger Comprehensive Cancer Center
  • Wake Forest University at Clemmons
  • Duke University Medical Center
  • East Carolina University
  • Duke Raleigh Hospital
  • Wake Forest Baptist Health - Wilkes Medical Center
  • Wake Forest University Health Sciences
  • Sanford Bismarck Medical Center
  • Sanford Broadway Medical Center
  • Sanford Roger Maris Cancer Center
  • MetroHealth Medical Center
  • Ohio State University Comprehensive Cancer Center
  • University of Oklahoma Health Sciences Center
  • Mercy Hospital Oklahoma City
  • Clackamas Radiation Oncology Center
  • Providence Cancer Institute Clackamas Clinic
  • Providence Newberg Medical Center
  • Providence Willamette Falls Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Lehigh Valley Hospital-Cedar Crest
  • UPMC Altoona
  • UPMC Camp Hill
  • Carlisle Regional Cancer Center
  • Christiana Care Health System-Concord Health Center
  • UPMC Hillman Cancer Center Erie
  • Saint Vincent Hospital
  • UPMC Cancer Center at UPMC Horizon
  • UPMC Cancer Centers - Arnold Palmer Pavilion
  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  • Penn State Milton S Hershey Medical Center
  • IRMC Cancer Center
  • Jefferson Hospital
  • UPMC-Johnstown/John P. Murtha Regional Cancer Center
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  • Forbes Hospital
  • UPMC Hillman Cancer Center - Part of Frick Hospital
  • Arnold Palmer Cancer Center Medical Oncology Norwin
  • UPMC Hillman Cancer Center - New Castle
  • Thomas Jefferson University Hospital
  • Allegheny General Hospital
  • UPMC-Saint Margaret
  • University of Pittsburgh Cancer Institute (UPCI)
  • UPMC-Shadyside Hospital
  • UPMC-Passavant Hospital
  • UPMC-Saint Clair Hospital Cancer Center
  • UPMC Cancer Center at UPMC Northwest
  • UPMC Cancer Center-Washington
  • UPMC Washington Hospital Radiation Oncology
  • Chester County Hospital
  • Wexford Health and Wellness Pavilion
  • Divine Providence Hospital
  • Asplundh Cancer Pavilion
  • UPMC Memorial
  • Medical University of South Carolina
  • Gibbs Cancer Center-Gaffney
  • Tidelands Georgetown Memorial Hospital
  • Prisma Health Cancer Institute - Faris
  • Prisma Health Cancer Institute - Eastside
  • Prisma Health Cancer Institute - Greer
  • Gibbs Cancer Center-Pelham
  • MUSC Health Tidelands Health Radiation Therapy Center
  • Prisma Health Cancer Institute - Seneca
  • Spartanburg Medical Center
  • MGC Hematology Oncology-Union
  • Lexington Medical Center
  • Sanford Cancer Center Oncology Clinic
  • Avera Cancer Institute
  • Sanford USD Medical Center - Sioux Falls
  • Avera Cancer Institute at Yankton
  • Baptist Memorial Hospital and Cancer Center-Collierville
  • The West Clinic - Wolf River
  • Baptist Memorial Hospital and Cancer Center-Memphis
  • Vanderbilt Breast Center at One Hundred Oaks
  • Vanderbilt University/Ingram Cancer Center
  • The Don and Sybil Harrington Cancer Center
  • Lyndon Baines Johnson General Hospital
  • M D Anderson Cancer Center
  • University of Texas Health Science Center at San Antonio
  • Farmington Health Center
  • University of Utah Sugarhouse Health Center
  • Huntsman Cancer Institute/University of Utah
  • Inova Schar Cancer InstituteRecruiting
  • Inova Fair Oaks HospitalRecruiting
  • Inova Fairfax HospitalRecruiting
  • Inova Loudoun HospitalRecruiting
  • Virginia Cancer Institute
  • VCU Massey Cancer Center at Stony Point
  • Virginia Commonwealth University/Massey Cancer Center
  • Valley Medical Center
  • Virginia Mason Medical CenterRecruiting
  • FHCC South Lake Union
  • Fred Hutchinson Cancer Research Center
  • University of Washington Medical Center - Montlake
  • Langlade Hospital and Cancer Center
  • Aurora Cancer Care-Southern Lakes VLCC
  • Marshfield Medical Center-EC Cancer Center
  • Aurora Health Care Germantown Health Center
  • Aurora Cancer Care-Grafton
  • Saint Vincent Hospital Cancer Center Green Bay
  • Saint Vincent Hospital Cancer Center at Saint Mary's
  • Aurora BayCare Medical Center
  • Aurora Cancer Care-Kenosha South
  • Aurora Bay Area Medical Group-Marinette
  • Marshfield Medical Center-Marshfield
  • Froedtert Menomonee Falls Hospital
  • Aurora Cancer Care-Milwaukee
  • Aurora Saint Luke's Medical Center
  • Medical College of Wisconsin
  • Aurora Sinai Medical Center
  • Marshfield Clinic-Minocqua Center
  • Drexel Town Square Health Center
  • Vince Lombardi Cancer Clinic - Oshkosh
  • Aurora Cancer Care-Racine
  • Marshfield Medical Center-Rice Lake
  • Saint Vincent Hospital Cancer Center at Sheboygan
  • Vince Lombardi Cancer Clinic-Sheboygan
  • Ascension Saint Michael's Hospital
  • Marshfield Medical Center-River Region at Stevens Point
  • Saint Vincent Hospital Cancer Center at Sturgeon Bay
  • Aurora Medical Center in Summit
  • Vince Lombardi Cancer Clinic-Two Rivers
  • Aspirus Regional Cancer Center
  • Aurora Cancer Care-Milwaukee West
  • Aurora West Allis Medical Center
  • Froedtert West Bend Hospital/Kraemer Cancer Center
  • Marshfield Medical Center - Weston
  • Aspirus Cancer Care - Wisconsin Rapids

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (LCRT, FOLFOX or CAPOX)

Group II (LCRT, FOLFIRINOX)

Arm Description

Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin IV, fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine PO, and oxaliplatin IV on study. Patients undergo CT scan, MRI, and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.

Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.

Outcomes

Primary Outcome Measures

Clincal Complete Response (cCR) Rates
efined as the number of patients who achieved cCR at the end of total neoadjuvant therapy (TNT) divided by number of patients included in the analysis population. This endpoint will be assessed within 8-12 weeks after completion of TNT. If there is a cCR, then the patient will be counted in the numerator. If there is a near-complete response (nCR) then a re-evaluation within 4-8 weeks will be performed. If the tumor has evolved to a cCR, then the patient will be counted in the numerator. Otherwise, the patient will be deemed as NOT achieving cCR status. divided by number of patients included in the analysis population.

Secondary Outcome Measures

Disease-free survival (DFS) rate
Defined as the time from date of randomization to the date of first occurrence of the following events: death due to all causes, tumor that recurs locally after an R0 total mesorectal excision (TME), tumor that regrows after an initial apparent clinical and radiological CR and cannot be surgically removed with an R0 TME, and M1 disease diagnosed at any point after the initiation of treatment.
Organ-preservation-time (OPT)
Defined as time from the date of randomization to the date of the first occurrence of the following events: TME performed or attempted, tumor that regrows after an initial apparent clinical and radiological complete response (CR), and death due to all causes.
Time to distant metastasis (TDM)
Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
Overall survival (OS)
Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
Incidence of adverse events (AEs)
Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The overall adverse event rates for grade 3 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).

Full Information

First Posted
November 1, 2022
Last Updated
August 30, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05610163
Brief Title
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation
Acronym
JANUS
Official Title
The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course neoadjuvant radiotherapy (LCRT) followed by neoadjuvant modified fluorouracil, irinotecan, leucovorin, and oxaliplatin (mFOLFIRINOX) versus neoadjuvant LCRT followed by neoadjuvant modified leucovorin , fluorouracil, and oxaliplatin (mFOLFOX6). SECONDARY OBJECTIVES: I. To evaluate and compare organ-preservation-time (OPT) between two treatment arms. II. To evaluate and compare the disease-free survival (DFS) time between the two treatment arms. III. To evaluate and compare time to distant metastasis between two treatment arms. IV. To evaluate and compare overall survival (OS) between two treatment arms. V. To evaluate and compare toxicity profiles of total neoadjuvant therapy (TNT) between two treatment arms. EXPLORATORY OBJECTIVE: I. Evaluation of circulating tumor deoxyribonucleic acid (ctDNA) kinetics during neoadjuvant therapy & surveillance and to correlate with radiographic, pathologic, and clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 arms. GROUP I: Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin intravenously (IV), fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine orally (PO), and oxaliplatin IV on study. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening. GROUP II: Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Carcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (LCRT, FOLFOX or CAPOX)
Arm Type
Active Comparator
Arm Description
Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin IV, fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine PO, and oxaliplatin IV on study. Patients undergo CT scan, MRI, and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.
Arm Title
Group II (LCRT, FOLFIRINOX)
Arm Type
Experimental
Arm Description
Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Leucovorin calcium
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Long Course Chemoradiotherapy
Intervention Description
Receive LCRT
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Intervention Description
undergo CT
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Sigmoidoscopy
Intervention Description
undergo sigmoidoscopy
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
undergo biopsy
Primary Outcome Measure Information:
Title
Clincal Complete Response (cCR) Rates
Description
efined as the number of patients who achieved cCR at the end of total neoadjuvant therapy (TNT) divided by number of patients included in the analysis population. This endpoint will be assessed within 8-12 weeks after completion of TNT. If there is a cCR, then the patient will be counted in the numerator. If there is a near-complete response (nCR) then a re-evaluation within 4-8 weeks will be performed. If the tumor has evolved to a cCR, then the patient will be counted in the numerator. Otherwise, the patient will be deemed as NOT achieving cCR status. divided by number of patients included in the analysis population.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS) rate
Description
Defined as the time from date of randomization to the date of first occurrence of the following events: death due to all causes, tumor that recurs locally after an R0 total mesorectal excision (TME), tumor that regrows after an initial apparent clinical and radiological CR and cannot be surgically removed with an R0 TME, and M1 disease diagnosed at any point after the initiation of treatment.
Time Frame
rom date of randomization, assessed up to 5 years
Title
Organ-preservation-time (OPT)
Description
Defined as time from the date of randomization to the date of the first occurrence of the following events: TME performed or attempted, tumor that regrows after an initial apparent clinical and radiological complete response (CR), and death due to all causes.
Time Frame
From date of randomization, assessed up to 5 years
Title
Time to distant metastasis (TDM)
Description
Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
Time Frame
From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years
Title
Overall survival (OS)
Description
Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
Time Frame
From the date of randomization to the date of death due to all causes, assessed up to 5 years
Title
Incidence of adverse events (AEs)
Description
Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The overall adverse event rates for grade 3 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis Tumor site: Rectum; =< 12cm from the anal verge No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for >= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for >= 6 months after the last treatment Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (or Karnofsky >= 60%) Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 50 mL/min ^3 Total bilirubin =< 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) No upper rectal tumors (distal margin of tumor > 12 cm from the anal verge) No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis No known mismatch repair deficient rectal adenocarcinoma Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J. Joshua Smith, MD
Phone
212-639-5807
Email
smithj5@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Joshua Smith, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mission Hope Medical Oncology - Arroyo Grande
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Individual Site Status
Suspended
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Suspended
Facility Name
Washington Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Suspended
Facility Name
City of Hope at Irvine Lennar
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Suspended
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Suspended
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Hospital - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Suspended
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Suspended
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Suspended
Facility Name
Salinas Valley Memorial
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Individual Site Status
Suspended
Facility Name
Mission Hope Medical Oncology - Santa Maria
City
Santa Maria
State/Province
California
ZIP/Postal Code
93444
Country
United States
Individual Site Status
Suspended
Facility Name
City of Hope South Pasadena
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Individual Site Status
Suspended
Facility Name
City of Hope South Bay
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Individual Site Status
Suspended
Facility Name
City of Hope Upland
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Suspended
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Francis Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Individual Site Status
Suspended
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Suspended
Facility Name
Midstate Medical Center
City
Meriden
State/Province
Connecticut
ZIP/Postal Code
06451
Country
United States
Individual Site Status
Suspended
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Individual Site Status
Suspended
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Individual Site Status
Suspended
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Individual Site Status
Suspended
Facility Name
Delaware Clinical and Laboratory Physicians PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Suspended
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Suspended
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Suspended
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Suspended
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Individual Site Status
Suspended
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Suspended
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Suspended
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph's Hospital-North
City
Lutz
State/Province
Florida
ZIP/Postal Code
33558
Country
United States
Individual Site Status
Suspended
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Anthony's Hospital Cancer Care Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph's Hospital/Children's Hospital-Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Individual Site Status
Suspended
Facility Name
Advocate Good Shepherd Hospital
City
Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Individual Site Status
Suspended
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Individual Site Status
Suspended
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Suspended
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Suspended
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Suspended
Facility Name
Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Suspended
Facility Name
AMG Crystal Lake - Oncology
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60014
Country
United States
Individual Site Status
Suspended
Facility Name
Carle at The Riverfront
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Individual Site Status
Suspended
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Suspended
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Suspended
Facility Name
Northwestern Medicine Cancer Center Kishwaukee
City
DeKalb
State/Province
Illinois
ZIP/Postal Code
60115
Country
United States
Individual Site Status
Suspended
Facility Name
Advocate Good Samaritan Hospital
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Individual Site Status
Suspended
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Individual Site Status
Suspended
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Individual Site Status
Suspended
Facility Name
Elmhurst Memorial Hospital
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Individual Site Status
Suspended
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Individual Site Status
Suspended
Facility Name
Advocate South Suburban Hospital
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Individual Site Status
Suspended
Facility Name
Northwestern Medicine Lake Forest Hospital
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Individual Site Status
Suspended
Facility Name
AMG Libertyville - Oncology
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Individual Site Status
Suspended
Facility Name
Condell Memorial Hospital
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Individual Site Status
Suspended
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Individual Site Status
Suspended
Facility Name
Edward Hospital/Cancer Center
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Suspended
Facility Name
UC Comprehensive Cancer Center at Silver Cross
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Individual Site Status
Suspended
Facility Name
Cancer Care Center of O'Fallon
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Individual Site Status
Suspended
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-2699
Country
United States
Individual Site Status
Suspended
Facility Name
University of Chicago Medicine-Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Individual Site Status
Suspended
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Suspended
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Suspended
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Individual Site Status
Suspended
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Suspended
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Suspended
Facility Name
Parkview Regional Medical Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Suspended
Facility Name
Oncology Associates at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Suspended
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Suspended
Facility Name
Greater Regional Medical Center
City
Creston
State/Province
Iowa
ZIP/Postal Code
50801
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Suspended
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Suspended
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Suspended
Facility Name
Lafayette Family Cancer Center-EMMC
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Individual Site Status
Suspended
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Suspended
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Individual Site Status
Suspended
Facility Name
Caro Cancer Center
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Suspended
Facility Name
Beaumont Hospital - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Individual Site Status
Suspended
Facility Name
Beaumont Hospital - Farmington Hills
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Individual Site Status
Suspended
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Suspended
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Suspended
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Mary's Oncology/Hematology Associates of Marlette
City
Marlette
State/Province
Michigan
ZIP/Postal Code
48453
Country
United States
Individual Site Status
Suspended
Facility Name
21st Century Oncology-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Suspended
Facility Name
William Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Suspended
Facility Name
Ascension Saint Mary's Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Individual Site Status
Suspended
Facility Name
Oncology Hematology Associates of Saginaw Valley PC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Individual Site Status
Suspended
Facility Name
Ascension Saint Joseph Hospital
City
Tawas City
State/Province
Michigan
ZIP/Postal Code
48764
Country
United States
Individual Site Status
Suspended
Facility Name
William Beaumont Hospital - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Mary's Oncology/Hematology Associates of West Branch
City
West Branch
State/Province
Michigan
ZIP/Postal Code
48661
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Suspended
Facility Name
Sanford Joe Lueken Cancer Center
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Individual Site Status
Suspended
Facility Name
Minnesota Oncology - Burnsville
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Suspended
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Suspended
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Suspended
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Suspended
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Individual Site Status
Suspended
Facility Name
Baptist Memorial Hospital and Cancer Center-Golden Triangle
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
Individual Site Status
Suspended
Facility Name
Baptist Cancer Center-Grenada
City
Grenada
State/Province
Mississippi
ZIP/Postal Code
38901
Country
United States
Individual Site Status
Suspended
Facility Name
Baptist Memorial Hospital and Cancer Center-Union County
City
New Albany
State/Province
Mississippi
ZIP/Postal Code
38652
Country
United States
Individual Site Status
Suspended
Facility Name
Baptist Memorial Hospital and Cancer Center-Oxford
City
Oxford
State/Province
Mississippi
ZIP/Postal Code
38655
Country
United States
Individual Site Status
Suspended
Facility Name
Baptist Memorial Hospital and Cancer Center-Desoto
City
Southhaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Individual Site Status
Suspended
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Suspended
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Suspended
Facility Name
OptumCare Cancer Care at Seven Hills
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Suspended
Facility Name
OptumCare Cancer Care at Charleston
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Suspended
Facility Name
Radiation Oncology Centers of Nevada Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Suspended
Facility Name
Radiation Oncology Centers of Nevada Southeast
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Suspended
Facility Name
OptumCare Cancer Care at MountainView
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Suspended
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Individual Site Status
Suspended
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Suspended
Facility Name
OptumCare Cancer Care at Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Suspended
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Suspended
Facility Name
New Hampshire Oncology Hematology PA-Concord
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Individual Site Status
Suspended
Facility Name
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Suspended
Facility Name
The Dana-Farber Cancer Institute at Londonderry
City
Londonderry
State/Province
New Hampshire
ZIP/Postal Code
03053
Country
United States
Individual Site Status
Suspended
Facility Name
Solinsky Center for Cancer Care
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Suspended
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Suspended
Facility Name
Montefiore Medical Center-Einstein Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Suspended
Facility Name
Montefiore Medical Center-Weiler Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Suspended
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Suspended
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Suspended
Facility Name
Northwell Health Cancer Institute at Huntington
City
Greenlawn
State/Province
New York
ZIP/Postal Code
11740
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Suspended
Facility Name
Northwell Health/Center for Advanced Medicine
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Suspended
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Suspended
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Suspended
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Suspended
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Suspended
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Suspended
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Suspended
Facility Name
Wilmot Cancer Institute at Webster
City
Webster
State/Province
New York
ZIP/Postal Code
14580
Country
United States
Individual Site Status
Suspended
Facility Name
Duke Cancer Institute Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Individual Site Status
Suspended
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Suspended
Facility Name
Wake Forest University at Clemmons
City
Clemmons
State/Province
North Carolina
ZIP/Postal Code
27012
Country
United States
Individual Site Status
Suspended
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Suspended
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Suspended
Facility Name
Duke Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Individual Site Status
Suspended
Facility Name
Wake Forest Baptist Health - Wilkes Medical Center
City
Wilkesboro
State/Province
North Carolina
ZIP/Postal Code
28659
Country
United States
Individual Site Status
Suspended
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Suspended
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Individual Site Status
Suspended
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Suspended
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Suspended
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Suspended
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Suspended
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Suspended
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Cancer Institute Clackamas Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Willamette Falls Medical Center
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Suspended
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Altoona
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Camp Hill
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Suspended
Facility Name
Carlisle Regional Cancer Center
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Individual Site Status
Suspended
Facility Name
Christiana Care Health System-Concord Health Center
City
Chadds Ford
State/Province
Pennsylvania
ZIP/Postal Code
19317
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Hillman Cancer Center Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Vincent Hospital
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Cancer Center at UPMC Horizon
City
Farrell
State/Province
Pennsylvania
ZIP/Postal Code
16121
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Cancer Centers - Arnold Palmer Pavilion
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Individual Site Status
Suspended
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Individual Site Status
Suspended
Facility Name
IRMC Cancer Center
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Individual Site Status
Suspended
Facility Name
Jefferson Hospital
City
Jefferson Hills
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC-Johnstown/John P. Murtha Regional Cancer Center
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15901
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17050
Country
United States
Individual Site Status
Suspended
Facility Name
Forbes Hospital
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Hillman Cancer Center - Part of Frick Hospital
City
Mount Pleasant
State/Province
Pennsylvania
ZIP/Postal Code
15666
Country
United States
Individual Site Status
Suspended
Facility Name
Arnold Palmer Cancer Center Medical Oncology Norwin
City
N. Huntingdon
State/Province
Pennsylvania
ZIP/Postal Code
15642
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Hillman Cancer Center - New Castle
City
New Castle
State/Province
Pennsylvania
ZIP/Postal Code
16105
Country
United States
Individual Site Status
Suspended
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Suspended
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC-Saint Margaret
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Individual Site Status
Suspended
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC-Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC-Passavant Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC-Saint Clair Hospital Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Cancer Center at UPMC Northwest
City
Seneca
State/Province
Pennsylvania
ZIP/Postal Code
16346
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Cancer Center-Washington
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Washington Hospital Radiation Oncology
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
Individual Site Status
Suspended
Facility Name
Chester County Hospital
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Individual Site Status
Suspended
Facility Name
Wexford Health and Wellness Pavilion
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Individual Site Status
Suspended
Facility Name
Divine Providence Hospital
City
Williamsport
State/Province
Pennsylvania
ZIP/Postal Code
17754
Country
United States
Individual Site Status
Suspended
Facility Name
Asplundh Cancer Pavilion
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Memorial
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17408
Country
United States
Individual Site Status
Suspended
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Suspended
Facility Name
Gibbs Cancer Center-Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Individual Site Status
Suspended
Facility Name
Tidelands Georgetown Memorial Hospital
City
Georgetown
State/Province
South Carolina
ZIP/Postal Code
29440
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Suspended
Facility Name
Gibbs Cancer Center-Pelham
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Individual Site Status
Suspended
Facility Name
MUSC Health Tidelands Health Radiation Therapy Center
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Individual Site Status
Suspended
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Suspended
Facility Name
MGC Hematology Oncology-Union
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Individual Site Status
Suspended
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Suspended
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Suspended
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Suspended
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Individual Site Status
Suspended
Facility Name
Avera Cancer Institute at Yankton
City
Yankton
State/Province
South Dakota
ZIP/Postal Code
57078
Country
United States
Individual Site Status
Suspended
Facility Name
Baptist Memorial Hospital and Cancer Center-Collierville
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Individual Site Status
Suspended
Facility Name
The West Clinic - Wolf River
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Suspended
Facility Name
Baptist Memorial Hospital and Cancer Center-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Suspended
Facility Name
Vanderbilt Breast Center at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Suspended
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Suspended
Facility Name
The Don and Sybil Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Suspended
Facility Name
Lyndon Baines Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026-1967
Country
United States
Individual Site Status
Suspended
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Suspended
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Suspended
Facility Name
Farmington Health Center
City
Farmington
State/Province
Utah
ZIP/Postal Code
84025
Country
United States
Individual Site Status
Suspended
Facility Name
University of Utah Sugarhouse Health Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Suspended
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Suspended
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-720-5210
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Jasmine Huynh
Facility Name
Inova Fair Oaks Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-720-5210
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Jasmine Huynh
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-208-6650
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Jasmine Huynh
Facility Name
Inova Loudoun Hospital
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-858-6000
Email
Keary.janet@inova.org
First Name & Middle Initial & Last Name & Degree
Jasmine Huynh
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Individual Site Status
Suspended
Facility Name
VCU Massey Cancer Center at Stony Point
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Suspended
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Suspended
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Individual Site Status
Suspended
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
206-287-6275
Email
cancerresearch@virginiamason.org
First Name & Middle Initial & Last Name & Degree
Huong T. Pham
Facility Name
FHCC South Lake Union
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Suspended
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Suspended
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Suspended
Facility Name
Langlade Hospital and Cancer Center
City
Antigo
State/Province
Wisconsin
ZIP/Postal Code
54409
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Cancer Care-Southern Lakes VLCC
City
Burlington
State/Province
Wisconsin
ZIP/Postal Code
53105
Country
United States
Individual Site Status
Suspended
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Health Care Germantown Health Center
City
Germantown
State/Province
Wisconsin
ZIP/Postal Code
53022
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Cancer Care-Grafton
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Vincent Hospital Cancer Center Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Vincent Hospital Cancer Center at Saint Mary's
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Cancer Care-Kenosha South
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Bay Area Medical Group-Marinette
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Individual Site Status
Suspended
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Suspended
Facility Name
Froedtert Menomonee Falls Hospital
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Cancer Care-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Suspended
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Sinai Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Individual Site Status
Suspended
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Individual Site Status
Suspended
Facility Name
Drexel Town Square Health Center
City
Oak Creek
State/Province
Wisconsin
ZIP/Postal Code
53154
Country
United States
Individual Site Status
Suspended
Facility Name
Vince Lombardi Cancer Clinic - Oshkosh
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54904
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Cancer Care-Racine
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States
Individual Site Status
Suspended
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Vincent Hospital Cancer Center at Sheboygan
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Individual Site Status
Suspended
Facility Name
Vince Lombardi Cancer Clinic-Sheboygan
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Individual Site Status
Suspended
Facility Name
Ascension Saint Michael's Hospital
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Individual Site Status
Suspended
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Vincent Hospital Cancer Center at Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235-1495
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Medical Center in Summit
City
Summit
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Individual Site Status
Suspended
Facility Name
Vince Lombardi Cancer Clinic-Two Rivers
City
Two Rivers
State/Province
Wisconsin
ZIP/Postal Code
54241
Country
United States
Individual Site Status
Suspended
Facility Name
Aspirus Regional Cancer Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora Cancer Care-Milwaukee West
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Suspended
Facility Name
Aurora West Allis Medical Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Individual Site Status
Suspended
Facility Name
Froedtert West Bend Hospital/Kraemer Cancer Center
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
Individual Site Status
Suspended
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Individual Site Status
Suspended
Facility Name
Aspirus Cancer Care - Wisconsin Rapids
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Individual Site Status
Suspended

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

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