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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


Intergroup Randomized Phase III Study Of Postoperative Irinotecan, 5-Fluorouracil And Leucovorin Vs Oxaliplatin, 5-Flourouracil And Leucovorin Vs 5-Fluorouracil And Leucovorin For Patients With Stage II or III Rectal Cancer Receiving Either Preoperative Radiation And 5-Fluorouracil Or Postoperative Radiation And 5-Flourouracil


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.


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.

Study Status: Active, not recruiting


Condition Intervention Phase
Colorectal Cancer Drug: FOLFIRI regimen
Drug: FOLFOX regimen
Drug: capecitabine
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 3

Verified by National Cancer Institute (NCI) November, 2005

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI) identifier: NCT00068692

Study Type: Interventional

Study Design: Allocation: Randomized, Primary Purpose: Treatment

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States

Al B. Benson, MD, FACP., Study Chair
Bruce J. Giantonio, MD.,
Neal J. Meropol, MD.,

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