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Anti-metabolites

Radiation Therapy + Fluorouracil for Rectal Cancer

Phase 2

Waitlist Available

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed invasive adenocarcinoma of the rectum with the distal border of the tumor within 12 cm from the anal verge as measured on rigid proctoscopic exam

Patients must have an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1, or comparable Karnofsky performance status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after surgery

Awards & highlights

Study Summary

This trial is studying radiation therapy and chemotherapy before surgery in treating patients with rectal cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include skin irritation from radiation, fatigue, nausea, mouth sores from fluorouracil; nerve damage like tingling or numbness from oxaliplatin; allergic reactions; blood count changes leading to infection risk; liver enzyme alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or able to carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ determined at the time of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~determined at the time of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and determined at the time of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of different chemoradiation-to-surgery intervals on postoperative complications

Effect of different chemoradiation-to-surgery intervals on rate of pathologic complete response and surgical difficulty.

Rate of pathologic complete response

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4 (chemotherapy, FOLFOX, conventional surgery)Experimental Treatment9 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 Treatment9 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 Treatment9 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 Treatment7 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..

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DNA analysis

2007

Completed Phase 2

~6450

leucovorin calcium

1999

Completed Phase 3

~8620