Study:
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
Rationale:
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.
Purpose:
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
Recruiting:
n/a
| 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)
ClinicalTrials.gov 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.,