Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Trial Summary
What is the purpose of this trial?
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus radiation therapy for anal cancer. PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer.
Research Team
Jaffer A. Ajani, MD
Principal Investigator
M.D. Anderson Cancer Center
Joel E. Tepper, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
John S. MacDonald, MD
Principal Investigator
Beth Israel Comprehensive Cancer Center - West Side Campus
Michael G. Haddock, MD
Principal Investigator
Mayo Clinic
Al B. Benson, MD, FACP
Principal Investigator
Robert H. Lurie Cancer Center
Eligibility Criteria
Inclusion Criteria
Treatment Details
Interventions
- Cisplatin (Platinum-based Compound)
- Fluorouracil (Anti-metabolites)
- Mitomycin (Antibiotics)
- Radiation Therapy (Radiation)
Cisplatin is already approved in Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Radiation Therapy Oncology Group
Lead Sponsor
Dr. Vivek S. Kavadi
Radiation Therapy Oncology Group
Chief Executive Officer
MD from Harvard Medical School, MBA from The Wharton School
Dr. Gita Suneja
Radiation Therapy Oncology Group
Chief Medical Officer
MD from University of Utah School of Medicine
Southwest Oncology Group
Collaborator
Dr. Lyudmila Bazhenova
Southwest Oncology Group
Chief Medical Officer since 2021
MD from University of California, San Diego
Dr. Richard Schilsky
Southwest Oncology Group
Chief Executive Officer since 2013
MD from University of California, San Diego
National Cancer Institute (NCI)
Collaborator
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School
Cancer and Leukemia Group B
Collaborator
Dr. Richard L. Schilsky
Cancer and Leukemia Group B
Chief Executive Officer since 2012
MD from University of Chicago
Dr. Walter Stadler
Cancer and Leukemia Group B
Chief Medical Officer since 2012
MD from Harvard Medical School
SWOG Cancer Research Network
Collaborator
Dr. Charles D. Blanke
SWOG Cancer Research Network
Chief Executive Officer since 2012
MD from Oregon Health & Science University
Dr. Dawn Hershman
SWOG Cancer Research Network
Chief Medical Officer since 2020
MD from Columbia University
North Central Cancer Treatment Group
Collaborator
Eastern Cooperative Oncology Group
Collaborator
Dr. Mitchell D. Schnall
Eastern Cooperative Oncology Group
Chief Medical Officer
MD, PhD from University of Pennsylvania
Dr. Peter J. O'Dwyer
Eastern Cooperative Oncology Group
Chief Executive Officer
MD from University of Pennsylvania