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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 2, 2000
Last updated: December 17, 2013
Last verified: March 2007

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.

Condition Intervention Phase
Colorectal Cancer
Drug: L-leucovorin
Drug: fluorouracil
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • All-cause mortality

Secondary Outcome Measures:
  • Death from colorectal cancer
  • Disease recurrence

Estimated Enrollment: 2500
Study Start Date: October 1997
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


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


Biologic therapy:

  • Not specified


  • No concurrent chemotherapy in observation only arm

Endocrine therapy:

  • Not specified


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


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00005586

United Kingdom
Royal London Hospital
London, England, United Kingdom, E1 1BB
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Study Chair: Norman Williams, MD Royal London Hospital
  More Information

Publications: Identifier: NCT00005586     History of Changes
Other Study ID Numbers: CDR0000067660
Study First Received: May 2, 2000
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on April 24, 2017