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Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

Primary Purpose

Anal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fluorouracil
mitomycin C
Intensity-modulated radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Cancer focused on measuring stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, basaloid carcinoma of the anus, cloacogenic carcinoma of the anus, squamous cell carcinoma of the anus

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoma of the anal canal, including any of the following subtypes:

    • Squamous cell
    • Basaloid
    • Cloacogenic
  • Primary invasive disease

  • T2-4, N0-3 disease

    • Clinically positive small inguinal nodes (i.e., < 1 cm in size) must be confirmed by biopsy (preferably fine-needle aspiration) within the past 6 weeks
    • Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on exam or CT scan that are found to be ≥ 1.0 cm and are considered to be clinically positive

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • ALT and AST < 3 times upper limit of normal
  • Absolute neutrophil count ≥ 1,800/mm³
  • Serum creatinine ≤ 1.5 mg/dL
  • Platelet count ≥ 100,000/mm³
  • Bilirubin < 1.4 mg/dL
  • WBC ≥ 3,000/mm³
  • INR ≤ 1.5

  • No known AIDS

    • HIV-positive patients without AIDS are eligible
    • HIV test required for patients with clinical suspicion of AIDS
  • No other invasive malignancy within the past 3 years except for nonmelanomatous skin cancer

  • No severe, active comorbidity, defined as any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

    • Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled high blood pressure, that in the opinion of the patient's treating physician, requires an immediate change in management

      • Patients may be eligible if appropriate changes in management have resulted in adequate control of the above mentioned conditions
    • Other immunocompromised status (e.g., organ transplantation or chronic glucocorticoid use)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields
  • No prior systemic chemotherapy for cancer of the anus
  • No prior surgery for cancer of the anus that removed all macroscopic anal cancer
  • No concurrent sargramostim (GM-CSF)
  • No concurrent amifostine

Sites / Locations

  • Arizona Oncology - Tucson
  • Auburn Radiation Oncology
  • Providence Saint Joseph Medical Center - Burbank
  • Radiation Oncology Centers - Cameron Park
  • Mercy Cancer Center at Mercy San Juan Medical Center
  • City of Hope Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Radiation Oncology Center - Roseville
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • Mercy General Hospital
  • Solano Radiation Oncology Center
  • University of Colorado Cancer Center at UC Health Sciences Center
  • Penrose Cancer Center at Penrose Hospital
  • Veterans Affairs Medical Center - Denver
  • St. Mary - Corwin Regional Medical Center
  • Tunnell Cancer Center at Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital
  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • Integrated Community Oncology Network
  • Baptist Cancer Institute - Jacksonville
  • Integrated Community Oncology Network at Southside Cancer Center
  • Baptist Medical Center South
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • Florida Oncology Associates
  • Florida Cancer Center - Palatka
  • Bay Medical
  • Flagler Cancer Center
  • Piedmont Hospital
  • Northwest Community Hospital
  • St. Joseph Medical Center
  • Graham Hospital
  • Memorial Hospital
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Eureka Community Hospital
  • Galesburg Clinic, PC
  • Galesburg Cottage Hospital
  • InterCommunity Cancer Center of Western Illinois
  • Mason District Hospital
  • Hopedale Medical Complex
  • Kewanee Hospital
  • McDonough District Hospital
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • BroMenn Regional Medical Center
  • Community Cancer Center
  • Community Hospital of Ottawa
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
  • Cancer Treatment Center at Pekin Hospital
  • OSF St. Francis Medical Center
  • CCOP - Illinois Oncology Research Association
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Methodist Medical Center of Illinois
  • Illinois Valley Community Hospital
  • Perry Memorial Hospital
  • St. Margaret's Hospital
  • Valley Cancer Center
  • Cancer Institute at St. John's Hospital
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Methodist Cancer Center at Methodist Hospital
  • Central Indiana Cancer Centers - East
  • St. Vincent Oncology Center
  • Reid Hospital & Health Care Services
  • Kansas City Cancer Centers - Southwest
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Union Hospital Cancer Program at Union Hospital
  • Boston University Cancer Research Center
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • University of Michigan Comprehensive Cancer Center
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Green Bay Oncology, Limited - Escanaba
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Dickinson County Healthcare System
  • Foote Memorial Hospital
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Sparrow Regional Cancer Center
  • St. Mary Mercy Hospital
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • St. John Macomb Hospital
  • Mayo Clinic Cancer Center
  • CCOP - Kansas City
  • Kansas City Cancer Centers - South
  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Kingsbury Center for Cancer Care at Cheshire Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cancer Institute of New Jersey at Cooper University Hospital - Camden
  • Monmouth Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • Frederick R. and Betty M. Smith Cancer Treatment Center
  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • New Mexico Cancer Center
  • CCOP - Hematology-Oncology Associates of Central New York
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Wayne Memorial Hospital, Incorporated
  • Wayne Radiation Oncology
  • Wilmed Radiation Oncology Services
  • McDowell Cancer Center at Akron General Medical Center
  • Summa Center for Cancer Care at Akron City Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Middletown Regional Hospital
  • Charles F. Kettering Memorial Hospital
  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Precision Radiotherapy at University Pointe
  • Cancer Treatment Center
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Willamette Valley Cancer Center - Eugene
  • St. Luke's Cancer Network at St. Luke's Hospital
  • Bryn Mawr Hospital
  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  • Cancer Center of Paoli Memorial Hospital
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center - Philadelphia
  • Frankford Hospital Cancer Center - Torresdale Campus
  • Albert Einstein Cancer Center
  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  • CCOP - MainLine Health
  • Lankenau Cancer Center at Lankenau Hospital
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • Medical City Dallas Hospital
  • Texas Oncology, PA at Texas Cancer Center Dallas Southwest
  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
  • Texas Oncology, PA at Texas Cancer Center - Sherman
  • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
  • American Fork Hospital
  • Sandra L. Maxwell Cancer Center
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center - East Campus
  • LDS Hospital
  • Utah Cancer Specialists at UCS Cancer Center
  • Huntsman Cancer Institute at University of Utah
  • Norris Cotton Cancer Center - North
  • Southwest Virginia Regional Cancer Center at Wellmonth Health
  • Harrison Medical Center
  • St. Francis Hospital
  • Cascade Cancer Center at Evergreen Hospital Medical Center
  • CCOP - Virginia Mason Research Center
  • Schiffler Cancer Center at Wheeling Hospital
  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  • Green Bay Oncology, Limited at St. Mary's Hospital
  • St. Mary's Hospital Medical Center - Green Bay
  • St. Vincent Hospital Regional Cancer Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Medical College of Wisconsin Cancer Center
  • Green Bay Oncology, Limited - Oconto Falls
  • Green Bay Oncology, Limited - Sturgeon Bay
  • Tom Baker Cancer Centre - Calgary
  • London Regional Cancer Program at London Health Sciences Centre
  • Hopital Notre-Dame du CHUM

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

5-FU + Mitomycin + IMRT

Arm Description

5-FU + Mitomycin + IMRT

Outcomes

Primary Outcome Measures

Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.

Secondary Outcome Measures

Number of Patients With Major Radiation Planning Deviations
Deviations in intensity-modulated radiation therapy technique (IMRT) planning were determined by central review by the radiation oncology co-chairs of the study.
Percentage of Subjects With Acute Adverse Events (AE)
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.
Percentage of Subjects With Late Adverse Events (AE)
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Late toxicities occur greater than 90 days from the start of treatment.
Clinical Complete Response Rate
A complete clinical response was defined as complete resolution of all palpable tumor determined by digital rectal exam and proctosigmoidoscopy supplemented with pelvic axial imaging.
Duration of Radiotherapy Treatment
Number of days from radiotherapy treatment start to radiotherapy treatment end
Five-year Rate of Overall Survival
Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Five-year Rate of Disease-free Survival
Disease-free survival time is defined as time from registration to the date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Local failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.
Five-Year Cumulative Incidence Rate of Local-regional Failure
Local-regional failure time is defined as time from registration to date of failure and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact. Local-regional failure is defined as a local or regional failure. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Regional failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.
Five-Year Cumulative Incidence Rate of Distant Failure
Distant failure time is defined as time from registration to the appearance of distant metastases and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.
Five-Year Cumulative Incidence Rate of Colostomy Failure
Colostomy failure time is defined as time from registration to the date of colostomy or abdominoperineal (A-P) resection and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.
Five-Year Rate of Colostomy-free Survival
Colostomy-free survival time is defined as time from registration to date of colostomy or abdominoperineal (A-P) resection, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.

Full Information

First Posted
January 16, 2007
Last Updated
February 7, 2019
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00423293
Brief Title
Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
Official Title
A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in treating patients with invasive anal cancer.
Detailed Description
OBJECTIVES: Primary Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil, and mitomycin C decreases the combined rate of gastrointestinal and genitourinary adverse events (grade II or greater) by at least 15% in the first 90 days after the start of treatment in patients with primary invasive carcinoma of the anal canal compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on clinical trial RTOG 98-11. Secondary Determine the feasibility of performing IMRT in these patients in a cooperative group setting. Evaluate adverse events experienced by patients treated with this regimen and to decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by 15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11. Evaluate the total duration of radiotherapy. Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free survival, time to colostomy, colostomy-free survival, and overall survival of these patients. Determine clinical complete response at 8 weeks after completion of study treatment. OUTLINE: This is a multicenter study. Patients receive mitomycin C IV over 10-30 minutes on days 1 and 29 and fluorouracil IV continuously over 96 hours on days 1-4 and 29-32. Patients also undergo dose-painted intensity-modulated radiation therapy once daily, 5 days a week, for 5½ to 6 weeks beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer
Keywords
stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, basaloid carcinoma of the anus, cloacogenic carcinoma of the anus, squamous cell carcinoma of the anus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-FU + Mitomycin + IMRT
Arm Type
Other
Arm Description
5-FU + Mitomycin + IMRT
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
1000 mg/m^2/day 96-hour continous infusion (M-F) starting on day 1 and again on day 29 of radiation therapy.
Intervention Type
Drug
Intervention Name(s)
mitomycin C
Intervention Description
10 mg/m^2 intravenous therapy on day 1 and day 29 of radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiation therapy
Intervention Description
Prescription dose depends on tumor staging. T2N0: The primary tumor PTV (planning target volume) (PTVA) receives 50.4 Gy in 28 fractions (fx) at 1.8 Gy/fx. The nodal PTVs receive 42 Gy in 28 fx at 1.5 Gy/fx. PTVA receive 50.4 Gy in 28 fractions at 1.8 Gy/fx. PTV42 receive 42 Gy in 28 fx at 1.5 Gy/fx and will include all nodal regions. T3N0 or T4N0: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. The nodal PTVs will receive 45 Gy in 30 fx at 1.5 Gy/fx. PTVA will receive 54 Gy in 30 fx at 1.80 Gy/fx. PTV45 will receive 45 Gy in 30 fx electively at 1.5 Gy/fx and will include all nodal regions. For N+ disease: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. For involved nodes ≤ 3 cm in maximum dimension, the involved nodal PTV will receive 50.4 Gy in 30 fx at 1.68 Gy/fx. For involved nodes > 3 cm in maximum dimension, the involved nodal PTV will receive 54 Gy in 30 fx at 1.80 Gy/fx.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)
Description
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.
Time Frame
From the start of treatment to 90 days
Secondary Outcome Measure Information:
Title
Number of Patients With Major Radiation Planning Deviations
Description
Deviations in intensity-modulated radiation therapy technique (IMRT) planning were determined by central review by the radiation oncology co-chairs of the study.
Time Frame
Planning occurred prior to radiation therapy
Title
Percentage of Subjects With Acute Adverse Events (AE)
Description
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.
Time Frame
From the start of treatment to 90 days
Title
Percentage of Subjects With Late Adverse Events (AE)
Description
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Late toxicities occur greater than 90 days from the start of treatment.
Time Frame
From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years.
Title
Clinical Complete Response Rate
Description
A complete clinical response was defined as complete resolution of all palpable tumor determined by digital rectal exam and proctosigmoidoscopy supplemented with pelvic axial imaging.
Time Frame
8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration)
Title
Duration of Radiotherapy Treatment
Description
Number of days from radiotherapy treatment start to radiotherapy treatment end
Time Frame
From start to end of radiation therapy (6 weeks)
Title
Five-year Rate of Overall Survival
Description
Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame
From registration to 5 years
Title
Five-year Rate of Disease-free Survival
Description
Disease-free survival time is defined as time from registration to the date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Local failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.
Time Frame
From registration to 5 years
Title
Five-Year Cumulative Incidence Rate of Local-regional Failure
Description
Local-regional failure time is defined as time from registration to date of failure and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact. Local-regional failure is defined as a local or regional failure. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Regional failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.
Time Frame
From registration to 5 years
Title
Five-Year Cumulative Incidence Rate of Distant Failure
Description
Distant failure time is defined as time from registration to the appearance of distant metastases and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.
Time Frame
From registration to 5 years
Title
Five-Year Cumulative Incidence Rate of Colostomy Failure
Description
Colostomy failure time is defined as time from registration to the date of colostomy or abdominoperineal (A-P) resection and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.
Time Frame
From registration to 5 years
Title
Five-Year Rate of Colostomy-free Survival
Description
Colostomy-free survival time is defined as time from registration to date of colostomy or abdominoperineal (A-P) resection, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
Time Frame
From registration to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the anal canal, including any of the following subtypes: Squamous cell Basaloid Cloacogenic Primary invasive disease T2-4, N0-3 disease Clinically positive small inguinal nodes (i.e., < 1 cm in size) must be confirmed by biopsy (preferably fine-needle aspiration) within the past 6 weeks Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on exam or CT scan that are found to be ≥ 1.0 cm and are considered to be clinically positive PATIENT CHARACTERISTICS: Zubrod performance status 0-1 Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) ALT and AST < 3 times upper limit of normal Absolute neutrophil count ≥ 1,800/mm³ Serum creatinine ≤ 1.5 mg/dL Platelet count ≥ 100,000/mm³ Bilirubin < 1.4 mg/dL WBC ≥ 3,000/mm³ INR ≤ 1.5 No known AIDS HIV-positive patients without AIDS are eligible HIV test required for patients with clinical suspicion of AIDS No other invasive malignancy within the past 3 years except for nonmelanomatous skin cancer No severe, active comorbidity, defined as any of the following: Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months Transmural myocardial infarction within the past 6 months Acute bacterial or fungal infection requiring IV antibiotics Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled high blood pressure, that in the opinion of the patient's treating physician, requires an immediate change in management Patients may be eligible if appropriate changes in management have resulted in adequate control of the above mentioned conditions Other immunocompromised status (e.g., organ transplantation or chronic glucocorticoid use) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields No prior systemic chemotherapy for cancer of the anus No prior surgery for cancer of the anus that removed all macroscopic anal cancer No concurrent sargramostim (GM-CSF) No concurrent amifostine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A. Kachnic, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Oncology - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Auburn Radiation Oncology
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Facility Name
Providence Saint Joseph Medical Center - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Radiation Oncology Centers - Cameron Park
City
Cameron Park
State/Province
California
ZIP/Postal Code
95682
Country
United States
Facility Name
Mercy Cancer Center at Mercy San Juan Medical Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Radiation Oncology Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Incorporated
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Solano Radiation Oncology Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
University of Colorado Cancer Center at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
St. Mary - Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Tunnell Cancer Center at Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Integrated Community Oncology Network
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Baptist Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Integrated Community Oncology Network at Southside Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Baptist Medical Center South
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Oncology Associates
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Florida Cancer Center - Palatka
City
Palatka
State/Province
Florida
ZIP/Postal Code
32177
Country
United States
Facility Name
Bay Medical
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Flagler Cancer Center
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwest Community Hospital
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
St. Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
InterCommunity Cancer Center of Western Illinois
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Kewanee Hospital
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7827
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
St. Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Valley Cancer Center
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Cancer Institute at St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Methodist Cancer Center at Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Central Indiana Cancer Centers - East
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
St. Vincent Oncology Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Reid Hospital & Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Kansas City Cancer Centers - Southwest
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Union Hospital Cancer Program at Union Hospital
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Green Bay Oncology, Limited - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Dickinson County Healthcare System
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Kansas City Cancer Centers - South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Kingsbury Center for Cancer Care at Cheshire Medical Center
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper University Hospital - Camden
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Frederick R. and Betty M. Smith Cancer Treatment Center
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Facility Name
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Radiation Oncology
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wilmed Radiation Oncology Services
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Precision Radiotherapy at University Pointe
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Willamette Valley Cancer Center - Eugene
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
St. Luke's Cancer Network at St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Cancer Center of Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Frankford Hospital Cancer Center - Torresdale Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37662
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology, PA at Texas Cancer Center - Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090
Country
United States
Facility Name
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
American Fork Hospital
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Sandra L. Maxwell Cancer Center
City
Cedar City
State/Province
Utah
ZIP/Postal Code
84720
Country
United States
Facility Name
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Norris Cotton Cancer Center - North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
Country
United States
Facility Name
Southwest Virginia Regional Cancer Center at Wellmonth Health
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
Harrison Medical Center
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
St. Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Cascade Cancer Center at Evergreen Hospital Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Schiffler Cancer Center at Wheeling Hospital
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Green Bay Oncology, Limited - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Green Bay Oncology, Limited - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

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