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A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

All-cause mortality

Safety Issue:

No

Principal Investigator

Norman Williams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Royal London Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067660

NCT ID:

NCT00005586

Start Date:

October 1997

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • Colorectal Neoplasms

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