Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over Other NCRI-QUASAR1 EU-99053, UKCCCR-QUASAR1, NCT00005586, ISRCTN82375386

Objectives

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

Entry Criteria

Disease Characteristics:

• Completely resected stage II or III colorectal cancer



• No distant metastases



• No positive resection margins



• No positive peritoneal washings

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

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

Expected Enrollment

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

Outcomes

All-cause mortality

Death from colorectal cancer
Disease recurrence

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.

Quasar Collaborative Group, Gray R, Barnwell J, et al.: Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet 370 (9604): 2020-9, 2007.[PUBMED Abstract]

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