Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00003063|
Recruitment Status : Unknown
Verified November 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: recombinant interferon alfa Drug: fluorouracil Drug: leucovorin calcium Drug: levamisole hydrochloride||Phase 3|
- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.
OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.
- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.
Patients are followed every 3 months for 2 years, then every 6 months.
PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1050 participants|
|Official Title:||Adjuvant Chemoimmunotherapy for Colorectal Cancer|
|Study Start Date :||November 1991|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003063
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|Study Chair:||Francesco Tonelli, MD||Universita Degli Studi di Florence - Policlinico di Careggi|