Trials / Unknown
UnknownNCT00003063
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Adjuvant Chemoimmunotherapy for Colorectal Cancer
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,050 (estimated)
- Sponsor
- European Institute of Oncology · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | recombinant interferon alfa | |
| DRUG | fluorouracil | |
| DRUG | leucovorin calcium | |
| DRUG | levamisole hydrochloride |
Timeline
- Start date
- 1991-11-01
- First posted
- 2003-01-27
- Last updated
- 2013-09-20
Locations
85 sites across 3 countries: Greece, Italy, South Korea
Source: ClinicalTrials.gov record NCT00003063. Inclusion in this directory is not an endorsement.