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S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed

NCT00002593 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1135

Last updated 2013-01-03

No results posted yet for this study

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 cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in different ways in treating patients with surgically removed stage II or stage III colon cancer at high risk of recurrence.

Conditions

Interventions

DRUG

fluorouracil

Given IV as described in Arm Description

DRUG

leucovorin calcium

Given IV as described in Arm description.

DRUG

levamisole hydrochloride

Given as described in arm description

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Elizabeth A. Poplin, MD · Rutgers Cancer Institute of New Jersey

  • Robert J. Mayer, MD, FACP · Dana-Farber Cancer Institute

  • Daniel G. Haller, MD · Abramson Cancer Center at Penn Medicine

  • Richard M. Goldberg, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-12-31
Primary Completion
1999-12-31
Completion
2005-03-31

Countries

  • United States
  • Canada
  • Puerto Rico
  • South Africa

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 NCT00002593 on ClinicalTrials.gov