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Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer

2014-07-23 21:57:03 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer

PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.

Description

OBJECTIVES: I. Compare the efficacy of leucovorin calcium plus fluorouracil with either irinotecan or oxaliplatin in terms of progression free survival in patients with recurrent metastatic colorectal cancer. II. Compare the efficacy, tolerance, quality of life, and overall survival in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and measurable or evaluable disease. Patients are randomized to receive either a 2 hour continuous infusion of irinotecan or a 2 hour continuous infusion of oxaliplatin on day 1. All patients receive a 2 hour continuous infusion of leucovorin calcium followed by IV bolus and 48 hour continuous infusion of fluorouracil on days 1 and 2. Courses are repeated every 2 weeks. Patients will receive the alternate treatment if disease progression or unacceptable toxicity occurs on their initial treatment. Patients are followed every 3 months after end of treatment.

PROJECTED ACCRUAL: This study will accrue a total of 109 patients per arm over approximately 18 months.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Colorectal Cancer

Intervention

FOLFIRI regimen, FOLFOX regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin

Location

Hopital Saint Antoine
Paris
France
75571

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:57:03-0400

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Medical and Biotech [MESH] Definitions

Voluntary cooperation of the patient in following a prescribed regimen.

Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.

A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A treatment program based on manipulation of the patient's environment by the medical staff. The patient does not participate in planning the treatment regimen.

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