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drugset / Trial / NCT00070434

S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum

NCT00070434 ↗

Phase 2 Withdrawn SWOG Cancer Research Network National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, 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. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum.

Timeline

Start
2004-08
Primary completion
2006-02
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 175 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous
Background Capecitabine Small molecule 825 mg/m2 Oral
Background Pyridoxine Unknown 50 mg Oral

Indications

colorectal cancer