MedTrace Logo

Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

NCT00002525 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 859

Last updated 2023-06-28

Study results available
· View outcomes & findings →

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 drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer.

PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.

Conditions

Interventions

DRUG

fluorouracil

Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5

DRUG

leucovorin calcium

given after surgery at dose of 20mg/m\^2 IV push on days 1-5

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • American College of Surgeons

    collaborator OTHER

  • NSABP Foundation Inc

    collaborator NETWORK

  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Mary M. Kemeny, MD, FACS · SUNY at Stony Brook

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-10-01
Primary Completion
2015-02-28
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002525 on ClinicalTrials.gov