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
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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 |
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 (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 |

- All-cause mortality
- Death from colorectal cancer
- Disease recurrence

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

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
United Kingdom | |
Royal London Hospital | |
London, England, United Kingdom, E1 1BB |
Study Chair: | Norman Williams, MD | Royal London Hospital |
ClinicalTrials.gov Identifier: | NCT00005586 |
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 |
stage II colon cancer stage III colon cancer stage II rectal cancer stage III rectal cancer |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Leucovorin Fluorouracil |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients |