Clinical Trial: Comparison of Adjuvant Chemotherapy Regimens in Treating Patients With Stage II or Stage III Rectal Cancer Who Are Receiving Radiation Therapy and Fluorouracil Before or After Surgery

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Intergroup Randomized Phase III Study of Postoperative Irinotecan, 5-Fluorouracil and Leucovorin vs. Oxaliplatin, 5-Fluorouracil and Leucovorin vs. 5-Fluorouracil and Leucovorin for Patients With Stag

Brief Summary: This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer

Detailed Summary:

PRIMARY OBJECTIVES:

I. To compare the overall survival of patients treated with irinotecan, 5-FU and leucovorin versus those treated with oxaliplatin, leucovorin and 5-FU versus those treated with leucovorin and 5-FU for patients with stage II and III rectal cancer.

SECONDARY OBJECTIVES:

I. To prospectively assess rectal function using the Patient Bowel Function/Uniscale questionnaire and the FACT Diarrhea Subscale in patients treated with an adjuvant program of pelvic radiation therapy and chemotherapy.

II. To correlate TS, DPD and TP expression (key targets for 5-FU); retention of chromosome 18q alleles and MSI with TGFβ1RII mutation (markers for 5-FU efficacy); ERCC1, ERCC2 and XPF expression (participants in repair of adducts from oxaliplatin); and p53 gene mutation in tumor tissue specimens with treatment efficacy.

III. To correlate tumor molecular prognostic markers (chromosome 18q allelic loss and MSI) with survival.

IV. To determine physician preference in regard to the radiation-chemotherapy sequence in the Intergroup.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), chemotherapy/radiotherapy sequence (preoperative vs postoperative), and risk group (high risk [T3, N+, M0 or T4, any N, M0] vs low risk [T1-2, N+, M0 or T3, N0, M0]). Patients are treated in 1 of 2 groups according to physician preference and then randomized to 1 of 3 treatment arms.

GROUP I (preoperative chemoradiotherapy and additional adjuvant chemotherapy): Preoperative chemora
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Overall survival [ Time Frame: 3 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Sphincter preservation [ Time Frame: Up to 10 years ]
  • Tolerance of treatment [ Time Frame: Up to 10 years ]
  • Patterns of failure [ Time Frame: Up to 10 years ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 10, 2003
Date Started: October 2003
Date Completion:
Last Updated: February 26, 2013
Last Verified: February 2013