Radiation Therapy + Fluorouracil for Rectal Cancer

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if combining radiation therapy with chemotherapy can shrink tumors in patients with stage II or III rectal cancer. The treatment aims to make tumors smaller and easier to remove while protecting normal cells. The study will also look at the timing of treatments and their effects on surgery and recovery.

Research Team

Julio Garcia-Aguilar, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with stage II or III rectal cancer, who can perform daily activities on their own or need some help (ECOG 0-1). They must have a tumor within 12 cm of the anal verge and no history of certain diseases like inflammatory bowel disease, familial adenomatous polyposis, or recent heart issues. Prior pelvic radiation treatments disqualify them. Adequate organ function and agreement to use birth control are required.

Inclusion Criteria

My rectal cancer is confirmed and is within 12 cm from the anal opening.

I can be part of the study if MRI can stage my condition due to a high-grade obstruction.

I have hereditary non-polyposis colorectal cancer and meet other study requirements.

Exclusion Criteria

I am allergic to 5-fluorouracil, leucovorin, or oxaliplatin.

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.0 times institutional upper limit of normal (ULN)

Serum creatinine =< 1.5 times ULN

Treatment Details

Interventions

• Conventional Surgery (Procedure)
• Fluorouracil (Anti-metabolites)
• Leucovorin Calcium (Folate Analog)
• Oxaliplatin (Platinum-based Chemotherapy)
• Radiation Therapy (Radiation Therapy)

Trial Overview The study tests how well radiation therapy combined with fluorouracil chemotherapy works compared to adding more drugs (oxaliplatin and leucovorin) before surgery. The goal is to shrink tumors and spare healthy tissue. It includes DNA analysis and other lab tests to see how patients respond.

Participant Groups

Group I: Group 4 (chemotherapy, FOLFOX, conventional surgery) Experimental Treatment 9 Interventions

All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil IV continuously over 24 hours 7 days a week for 6 weeks. Beginning 4 weeks after completion of chemoradiation therapy, patients receive modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 6 courses. After the last week of post- radiation chemotherapy, patients undergo standard surgical resection. Patients then receive 3 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician.

Group II: Group 3 (chemotherapy, FOLFOX, conventional surgery) Experimental Treatment 9 Interventions

All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil IV continuously over 24 hours 7 days a week for 6 weeks. Beginning 4 weeks after completion of chemoradiation therapy, patients receive modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 4 courses. After the last week of post-radiation chemotherapy, patients undergo standard surgical resection.

Group III: Group 2 (Closed to Enrollment) Experimental Treatment 9 Interventions

All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil IV continuously over 24 hours 7 days a week for 6 weeks. Beginning 4 weeks after completion of chemoradiation therapy, patients receive modified FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1-2. Treatment repeats every 14 days for 2 courses. After the last week of post-radiation chemotherapy, patients undergo standard surgical resection.

Group IV: Group 1 (Closed to Enrollment) Experimental Treatment 7 Interventions

All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil intravenously continuously over 24 hours 7 days a week for 6 weeks. Patients undergo standard surgical resection after completion of chemoradiation therapy..

Fluorouracil is already approved in Canada for the following indications:

Approved in Canada as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+