Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

December 17, 2013 updated by: Institute of Cancer Research, United Kingdom

A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer

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 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.

PURPOSE: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare all-cause mortality in patients with resected colorectal cancer treated with adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation.
  • Compare the recurrence rates in patients treated with this regimen vs observation.
  • Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of L-leucovorin and fluorouracil in this patient population.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).

  • Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks.
  • Arm II: Patients undergo observation. Patients are followed annually.

PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

2500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, E1 1BB
        • Royal London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Completely resected stage II or III colorectal cancer
  • No distant metastases
  • No positive resection margins
  • No positive peritoneal washings

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No clear definite indication for, or contraindication against, systemic chemotherapy with L-leucovorin and fluorouracil

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No concurrent chemotherapy in observation only arm

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Concurrent radiotherapy allowed in adjuvant chemotherapy arm provided chemotherapy administered on the once weekly schedule

Surgery:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
All-cause mortality

Secondary Outcome Measures

Outcome Measure
Disease recurrence
Death from colorectal cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Investigators

  • Study Chair: Norman Williams, MD, Royal London Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067660
  • NCRI-QUASAR1
  • EU-99053
  • UKCCCR-QUASAR1
  • ISRCTN82375386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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