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Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study

Primary Purpose

Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Ablative Radiotherapy
Resection
Microwave Ablation
Chemotherapy
Computed Tomography
Magnetic Resonance Imaging
Positron Emission Tomography
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 Metastatic Colorectal Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria: PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy. Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required. Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study. Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and/or stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility. Single sites include: Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1 REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months) REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects. * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required REGISTRATION (STEP 1): Age >= 18 years REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 REGISTRATION (STEP 1): Absolute neutrophil count (ANC) >= 1,500/mm^3 REGISTRATION (STEP 1): Platelet count >= 50,000/mm^3 REGISTRATION (STEP 1): Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min * Calculated using the Cockcroft-Gault equation REGISTRATION (STEP 1): Total bilirubin =< 1.5 x ULN REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN * In the event of metastatic liver disease, =< 5 x ULN REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study Exclusion Criteria: N/A

Sites / Locations

  • University of California Davis Comprehensive Cancer CenterRecruiting
  • University of Florida Health Science Center - GainesvilleRecruiting
  • Medical Oncology and Hematology Associates-West Des MoinesRecruiting
  • Mercy Cancer Center-West LakesRecruiting
  • Greater Regional Medical CenterRecruiting
  • Mercy Medical Center - Des MoinesRecruiting
  • Mission Cancer and Blood - LaurelRecruiting
  • Mercy Medical Center-West LakesRecruiting
  • University of Kentucky/Markey Cancer CenterRecruiting
  • Saint Joseph Mercy HospitalRecruiting
  • Saint Joseph Mercy BrightonRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
  • Saint Joseph Mercy CantonRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
  • Saint Joseph Mercy ChelseaRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
  • Genesys Hurley Cancer InstituteRecruiting
  • Hurley Medical CenterRecruiting
  • Sparrow HospitalRecruiting
  • Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
  • Sanford Joe Lueken Cancer CenterRecruiting
  • Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
  • Baptist Cancer Center-GrenadaRecruiting
  • Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
  • Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
  • Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
  • Mercy Hospital Saint LouisRecruiting
  • Billings Clinic Cancer CenterRecruiting
  • Benefis Healthcare- Sletten Cancer InstituteRecruiting
  • Nebraska Medicine-BellevueRecruiting
  • Nebraska Medicine-Village PointeRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Renown Regional Medical CenterRecruiting
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • University of New Mexico Cancer CenterRecruiting
  • Memorial Sloan Kettering CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Northwell Health/Center for Advanced MedicineRecruiting
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of RochesterRecruiting
  • Memorial Sloan Kettering NassauRecruiting
  • Sanford Broadway Medical CenterRecruiting
  • Sanford Roger Maris Cancer CenterRecruiting
  • Dayton Physicians LLC-Miami Valley SouthRecruiting
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
  • Miami Valley Hospital NorthRecruiting
  • Atrium Medical Center-Middletown Regional HospitalRecruiting
  • Dayton Physicians LLC-AtriumRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Sanford Cancer Center Oncology ClinicRecruiting
  • Sanford USD Medical Center - Sioux FallsRecruiting
  • Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 (TAT, SOC chemotherapy

Arm 2 (SOC chemotherapy)

Arm Description

Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo CT or MRI or PET/CT scans throughout the trial.

Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
o Description: The hazard ratio (HR) for OS will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. The Kaplan-Meier methodology will be used to estimate the median OS for each treatment arm, and Kaplan-Meier curves will be produced. OS will also be compared between treatment arms using the log rank test

Secondary Outcome Measures

Event Free Survival (EFS)
The hazard ratio (HR) for EFS will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. The Kaplan-Meier methodology will be used to estimate the median EFS for each treatment arm, and Kaplan-Meier curves will be produced. EFS will also be compared between treatment arms using the log rank test.
• Incidence of Adverse Events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0)
Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient. The frequency tables will be reviewed to determine the patterns. 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 to local recurrence (TLR)
TLR will be measured only for patients who receive treatment with TAT and is defined as the time from the end of TAT until the date of first documented recurrence at any disease site treated with TAT. The Kaplan-Meier methodology will be used to estimate the median TLR for patients treated with TAT , and a Kaplan-Meier curve will be produced.

Full Information

First Posted
December 21, 2022
Last Updated
July 21, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05673148
Brief Title
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
Official Title
A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
June 3, 2028 (Anticipated)
Study Completion Date
August 12, 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
No

5. Study Description

Brief Summary
This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate and compare overall survival (OS) (measured from time of randomization) in patients with newly diagnosed oligometastatic colorectal cancer (oCRC) treated with total ablative therapy (TAT) in addition to standard of care (SOC) systemic therapy versus SOC systemic therapy. SECONDARY OBJECTIVES: I. To evaluate and compare event-free survival (EFS) (measured from time of randomization) between the two treatment arms. II. To assess the adverse events (AE) profile within each of the two treatment arms. III. To evaluate the time to local recurrence (TLR) (measured from completion of TAT) in patients with newly diagnosed oCRC treated with TAT + SOC systemic therapy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans throughout the trial. ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
364 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (TAT, SOC chemotherapy
Arm Type
Experimental
Arm Description
Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Arm Title
Arm 2 (SOC chemotherapy)
Arm Type
Active Comparator
Arm Description
Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Intervention Type
Procedure
Intervention Name(s)
Stereotactic Ablative Radiotherapy
Other Intervention Name(s)
SABER, SABR/SBRT
Intervention Description
Undergo SABR
Intervention Type
Procedure
Intervention Name(s)
Resection
Other Intervention Name(s)
Surgical resection
Intervention Description
undergo surgical resection
Intervention Type
Procedure
Intervention Name(s)
Microwave Ablation
Other Intervention Name(s)
Ablation
Intervention Description
undergo microwave ablation
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Chemo
Intervention Description
Receive SOC chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, CT Scan
Intervention Description
Undergo CT scan
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan
Intervention Description
Undergo PET scan
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
o Description: The hazard ratio (HR) for OS will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. The Kaplan-Meier methodology will be used to estimate the median OS for each treatment arm, and Kaplan-Meier curves will be produced. OS will also be compared between treatment arms using the log rank test
Time Frame
From the date of randomization to the date of death due to all causes, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Event Free Survival (EFS)
Description
The hazard ratio (HR) for EFS will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. The Kaplan-Meier methodology will be used to estimate the median EFS for each treatment arm, and Kaplan-Meier curves will be produced. EFS will also be compared between treatment arms using the log rank test.
Time Frame
From randomization to the date of first documented progression, recurrence, or death due to all causes, whichever occurs first, assessed up to 5 years
Title
• Incidence of Adverse Events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0)
Description
Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient. The frequency tables will be reviewed to determine the patterns. 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
Title
Time to local recurrence (TLR)
Description
TLR will be measured only for patients who receive treatment with TAT and is defined as the time from the end of TAT until the date of first documented recurrence at any disease site treated with TAT. The Kaplan-Meier methodology will be used to estimate the median TLR for patients treated with TAT , and a Kaplan-Meier curve will be produced.
Time Frame
from the end of TAT to the date of first documented recurrence at any disease site treated with TAT, assessed up to 5 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy. Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required. Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study. Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and/or stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility. Single sites include: Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1 REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months) REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects. * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required REGISTRATION (STEP 1): Age >= 18 years REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 REGISTRATION (STEP 1): Absolute neutrophil count (ANC) >= 1,500/mm^3 REGISTRATION (STEP 1): Platelet count >= 50,000/mm^3 REGISTRATION (STEP 1): Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min * Calculated using the Cockcroft-Gault equation REGISTRATION (STEP 1): Total bilirubin =< 1.5 x ULN REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN * In the event of metastatic liver disease, =< 5 x ULN REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study Exclusion Criteria: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric D. Miller, MD, PhD
Phone
614-685-4922
Email
eric.miller@osumc.edu
Facility Information:
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
916-734-3089
First Name & Middle Initial & Last Name & Degree
Rashmi Verma
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
352-273-8010
Email
cancer-center@ufl.edu
First Name & Middle Initial & Last Name & Degree
Kathryn E. Hitchcock
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Greater Regional Medical Center
City
Creston
State/Province
Iowa
ZIP/Postal Code
50801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
859-257-3379
First Name & Middle Initial & Last Name & Degree
Michael J. Cavnar
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Saint Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
517-364-9400
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Sanford Joe Lueken Cancer Center
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
218-333-5000
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-226-1366
Email
BCCclintrials@bmhcc.org
First Name & Middle Initial & Last Name & Degree
Aleksandar Jankov
Facility Name
Baptist Cancer Center-Grenada
City
Grenada
State/Province
Mississippi
ZIP/Postal Code
38901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-226-1366
Email
BCCclintrials@bmhcc.org
First Name & Middle Initial & Last Name & Degree
Aleksandar Jankov
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-226-1366
Email
BCCclintrials@bmhcc.org
First Name & Middle Initial & Last Name & Degree
Aleksandar Jankov
Facility Name
Baptist Memorial Hospital and Cancer Center-Oxford
City
Oxford
State/Province
Mississippi
ZIP/Postal Code
38655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-226-1366
Email
BCCclintrials@bmhcc.org
First Name & Middle Initial & Last Name & Degree
Aleksandar Jankov
Facility Name
Baptist Memorial Hospital and Cancer Center-Desoto
City
Southhaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-226-1366
Email
BCCclintrials@bmhcc.org
First Name & Middle Initial & Last Name & Degree
Aleksandar Jankov
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-251-7066
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-996-2663
Email
research@billingsclinic.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Nebraska Medicine-Bellevue
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-559-6941
Email
unmcrsa@unmc.edu
First Name & Middle Initial & Last Name & Degree
Laura L. Tenner
Facility Name
Nebraska Medicine-Village Pointe
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-559-5600
First Name & Middle Initial & Last Name & Degree
Laura L. Tenner
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-559-6941
Email
unmcrsa@unmc.edu
First Name & Middle Initial & Last Name & Degree
Laura L. Tenner
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-639-6918
Email
cancer.research.nurse@dartmouth.edu
First Name & Middle Initial & Last Name & Degree
Kathryn C. Hourdequin
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Vonetta M. Williams
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Vonetta M. Williams
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Vonetta M. Williams
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
505-925-0348
Email
HSC-ClinicalTrialInfo@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Benny J. Liem
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Vonetta M. Williams
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Vonetta M. Williams
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
516-734-8896
First Name & Middle Initial & Last Name & Degree
Sepideh Gholami
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-305-6361
Email
nr2616@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
David P. Horowitz
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Vonetta M. Williams
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
585-275-5830
First Name & Middle Initial & Last Name & Degree
Yuhchyau Chen
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Vonetta M. Williams
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-323-5760
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-234-6161
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Dayton Physicians LLC-Miami Valley South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Howard M. Gross
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-293-5066
Email
Jamesline@osumc.edu
First Name & Middle Initial & Last Name & Degree
Eric D. Miller
Facility Name
Dayton Physician LLC-Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Howard M. Gross
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
Facility Name
Dayton Physicians LLC-Atrium
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Howard M. Gross
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Sagila George
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicTrialsSF@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicalTrialsSF@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Baptist Memorial Hospital and Cancer Center-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-226-1366
Email
BCCclintrials@bmhcc.org
First Name & Middle Initial & Last Name & Degree
Aleksandar Jankov
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-450-3800
Email
phoresearchoffice@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Neil Newman

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study

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