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Combination Chemotherapy in Treating Patients With Stage III Colon Cancer

NCT00003835 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1260

Last updated 2013-10-08

No results posted yet for this study

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.

Conditions

  • Adenocarcinoma of the Colon
  • Stage III Colon Cancer

Interventions

DRUG

leucovorin calcium

Given IV

DRUG

fluorouracil

Given IV

DRUG

irinotecan hydrochloride

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • SWOG Cancer Research Network

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Leonard Saltz · Cancer and Leukemia Group B

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-31
Primary Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00003835 on ClinicalTrials.gov