drugset / Trial / NCT00422864

A Single Arm Trial of Oxaliplatin and 5FU With Concurrent Radiation in Patients With Metastatic Rectal Cancer

NCT00422864 ↗

Phase 2 Completed 26 enrolled Peter MacCallum Cancer Centre, Australia
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This trial is a single-arm study for patients presenting with both local and metastatic adenocarcinoma of rectum. The aims of the trial are (1) to determine the tolerability rate, and (2) to determine toxicity rates, pelvic and distant response rates in patients with locally advanced rectal cancer in the presence of distant metastasis who are treated with an interdigitating chemotherapy (oxaliplatin/5-fluorouracil \[5FU\]) and radiotherapy regimen.

Timeline

Start
2006-10
Primary completion
2009-06
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject Oxaliplatin Small molecule 100 mg/m2 —
Subject fluorouracil Small molecule 200 mg/m2 —
Subject fluorouracil Small molecule 400 mg/m2 —
Subject fluorouracil Small molecule 2.4 g —
Background Leucovorin Small molecule 200 mg/m2 —

Indications