A PHASE III STUDY OF IMMEDIATE VERSUS DELAYED CHEMOTHERAPY FOR ASYMPTOMATIC ADVANCED COLORECTAL CANCER
OBJECTIVES: I. Compare survival and quality of life in asymptomatic patients with advanced
colorectal cancer randomized to immediate fluorouracil/leucovorin (5-FU/CF) vs. 5-FU/CF
delayed until onset of symptoms.
OUTLINE: Randomized, unblinded study. Arm I: Single-Agent Chemotherapy with Drug Modulation.
Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Arm II: Observation
followed by Single-Agent Chemotherapy with Drug Modulation. Clinical observation until
symptomatic; followed by 5-FU; with CF.
PROJECTED ACCRUAL: 144 patients will be entered over 4 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
8 years
No
Malcolm J. Moore, MD
Study Chair
Princess Margaret Hospital, Canada
United States: Federal Government
CO10
NCT00002570
July 1994
February 2009
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |