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

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ClinicalTrials.gov Identifier: NCT00005586
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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 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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: L-leucovorin Drug: fluorouracil Procedure: adjuvant therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer
Study Start Date : October 1997

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality

Secondary Outcome Measures :
  1. Death from colorectal cancer
  2. Disease recurrence

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005586


Locations
United Kingdom
Royal London Hospital
London, England, United Kingdom, E1 1BB
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Study Chair: Norman Williams, MD Royal London Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

ClinicalTrials.gov Identifier: NCT00005586     History of Changes
Other Study ID Numbers: CDR0000067660
NCRI-QUASAR1
EU-99053
UKCCCR-QUASAR1
ISRCTN82375386
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: March 2007

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Fluorouracil
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents