drugset / Trial / NCT00081289

Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

NCT00081289 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy 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. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

Timeline

Start
2004-03
Primary completion
2011-05
Completion
2016-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1200 mg/m2 Oral
Subject Capecitabine Small molecule 1650 mg/m2 Oral
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 50 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications