QUASAR
QUASAR: adjuvant chemotherapy versus observation in patients with colorectal cancer at low risk of recurrence
Phase 3N = 3,239NCT00005586
- Population
- 3239 patients after apparently curative resection of colon or rectal cancer: 2963 (91%) with stage II (node-negative) disease and 2291 (71%) with colon cancer; median age 63 years.
- Design
- Randomised comparison of fluorouracil plus folinic acid with observation (chemotherapy considered on recurrence) after apparently curative resection of colon or rectal cancer; 150 centres in 19 countries, enrolled between May 1994 and December 2003. Chemotherapy: six 5-day courses every 4 weeks or 30 once-weekly courses of intravenous fluorouracil 370 mg/m2 with high-dose (175 mg) or low-dose (25 mg) L-folinic acid; until 1997 levamisole or placebo was added. Primary outcome all-cause mortality; analyses by intention to treat. Registered ISRCTN82375386 (abstract). The abstract states no phase; ClinicalTrials.gov NCT00005586, a legacy NCI record that lists ISRCTN82375386 as a secondary identifier, lists phase 3, whereas the ISRCTN record lists phase 'Not Specified'.
- Primary endpoint
- All-cause mortality
- Arms
- Fluorouracil plus folinic acid (experimental, n = 1,622): Fluorouracil plus L-folinic acid (six 5-day courses every 4 weeks or 30 once-weekly courses); levamisole or placebo added until 1997
- Observation (control, n = 1,617): Observation, with chemotherapy considered on recurrence
- People
- Quasar Collaborative Group, Quasar Collaborative Group