CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,151 enrolled
Drug / intervention
fluorouracil +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00425152
NCT00425152Phase 3Completed

A Clinical Trial to Assess the Relative Efficacy of 5-FU + Leucovorin, 5-FU + Levamisole, and 5-FU + Leucovorin + Levamisole in Patients With Dukes' B and C Carcinoma of the Colon

NSABP Foundation Inc·interventional·Posted Jan 22, 2007·Updated Feb 8, 2010

In Brief

A Phase 3 clinical trial evaluating fluorouracil, leucovorin calcium, and 1 other intervention for Colorectal Cancer. Completed, enrolled 2,151 participants.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors. It is not yet known whether fluorouracil is more effective when given together with leucovorin and/or levamisole after surgery in treating colon cancer. PURPOSE: This randomized phase III trial is studying giving fluorouracil together with leucovorin to see how well it works compared with giving fluorouracil together with levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in treating patients with Dukes' B or Dukes' C colon cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 3CompletedFinished
198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 22, 2007
Enrollment StartJul 1, 1989
Primary CompletionJun 1, 1998
Study CompletionApr 1, 2004
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 19.4 years ago

Interventions

fluorouracildrug

leucovorin calciumdrug

levamisole hydrochloridedrug