Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
Recruitment status was Active, not recruiting
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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with that of no further therapy in treating patients who have stage II or stage III colon cancer that can be surgically removed.
Drug: leucovorin calcium
Procedure: surgical procedure
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE III INTERGROUP PROSPECTIVELY RANDOMIZED TRIAL OF PERI-OPERATIVE 5-FU AFTER CURATIVE RESECTION, FOLLOWED BY 5-FU/LEVAMISOLE FOR PATIENTS WITH COLON CANCER|
|Study Start Date:||August 1993|
OBJECTIVES: I. Compare survival, disease free survival, and locoregional and distant metastases recurrence rates of patients with stage IIC or stage III colon cancer treated with curative colon resection with or without perioperative fluorouracil, followed by fluorouracil and leucovorin calcium. II. Compare survival and disease free survival in patients with stage IIB colon cancer treated with curative colon resection with or without perioperative fluorouracil.
OUTLINE: This is a randomized study. Patients undergo curative colon resection via laparotomy. Patients are randomized to 1 of 2 arms. Arm I: Within 24 hours of the colon resection, patients receive perioperative fluorouracil IV over 24 hours for 7 days. Arm II: Patients receive no perioperative fluorouracil. After surgery, patients with stage I, stage IIA, or stage IV colon cancer are immediately removed from study. Patients with stage IIB, IIC, or III colon cancer are reregistered within 35 days postoperatively. Beginning 21-35 days after surgery, patients with stage IIC or III disease receive leucovorin calcium IV bolus immediately followed by fluorouracil IV bolus on days 1-5. Courses repeat every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stage IIB disease do not receive adjuvant fluorouracil and leucovorin calcium. Patients are followed every 3 months for 2 years, then every 6 months for 2 years, and then annually.
PROJECTED ACCRUAL: A total of 800-2,000 patients (at least 400 per treatment arm) will be accrued for this study over 2-3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002525
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Study Chair:||Mary M. Kemeny, MD, FACS||Queens Cancer Center of Queens Hospital|
|Study Chair:||Robert P. Whitehead, MD||UMC Southwest Cancer and Research Center|
|Study Chair:||Terry Mamounas, MD, MPH, FACS||Aultman Cancer Center at Aultman Hospital|
|Study Chair:||Francis Joseph Harford, MD||Loyola University|