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Clinical Trials (PDQ®)

  • First Published: 5/1/2000
  • Last Modified: 5/13/2008

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Clinical Trials (PDQ®)

Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Adjuvant Chemotherapy With L-leucovorin and Fluorouracil Versus Observation in Patients With Resected Colorectal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overOtherNCRI-QUASAR1
EU-99053, UKCCCR-QUASAR1, NCT00005586, ISRCTN82375386

Trial Description

Purpose:

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 whether chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer.

This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Some patients in group one will receive infusions of leucovorin and fluorouracil for 5 days every 4 weeks for six courses. Other patients will receive infusions of leucovorin and fluorouracil once a week for 30 weeks. Patients in group two will receive observation. All patients will be evaluated once a year.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

National Cancer Research Institute

Norman Williams, MD, Protocol chair
Ph: 44-20-7377-7079
Email: norman.williams@bartsandthelondon.nhs.uk

Registry Information
Official Title A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer
Trial Start Date 1997-10-26
Registered in ClinicalTrials.gov NCT00005586
Date Submitted to PDQ 2000-01-13
Information Last Verified 2007-03-26

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