Clinical trial NCT00005586: Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Official title: A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: All-cause mortality
Secondary outcomes:
measure: Death from colorectal cancer
measure: Disease recurrence
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital
state: England
Study officials:
affiliation: Royal London Hospital
name: Norman Williams, MD
role: STUDY_CHAIR
References:
citation: Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.