At a glance
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A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum
In Brief
A Phase 3 clinical trial evaluating capecitabine, fluorouracil, and 2 other interventions for Colorectal Cancer. Targeting 1,608 participants.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in 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. PURPOSE: This randomized phase III trial is studying radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well they work when given before surgery in treating patients with resectable rectal cancer. It is not yet known whether radiation therapy and either capecitabine or fluorouracil is more effective with or without oxaliplatin in treating rectal cancer.
Study Details
Timeline
Interventions
825 mg/m2 oral daily 5 days a week on days of planned RT
225 mg/m2 IV daily continuous infusion
50 mg/m2 IV 5 days a week on days of planned RT
Given 5 days a week for 5-6 weeks