Suspended

Adjuvant Chemoimmunotherapy for Colorectal Cancer

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What is being tested

recombinant interferon alfa

+ fluorouracil

+ leucovorin calcium

BiologicalDrug
Who is being recruted

Colonic Diseases+10

+ Digestive System Diseases

+ Digestive System Neoplasms

Until 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 1991
See protocol details

Summary

Principal SponsorEuropean Institute of Oncology
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1991

Actual date on which the first participant was enrolled.

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.

NCT00003063
Principal SponsorEuropean Institute of Oncology
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1050 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColonic NeoplasmsRectal NeoplasmsColorectal Neoplasms

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer No evidence of residual disease after surgery Tumor located above peritoneal reflection No distant metastases PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGPT less than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No serious cardiac ischemia Other: Adequate metabolic functions No prior neoplasm No prior/concurrent illness No insulin-dependent diabetes PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for the current cancer Chemotherapy No prior chemotherapy for the current cancer Endocrine therapy Not specified Radiotherapy No prior radiotherapy for the current cancer Surgery Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 85 locations

George Papanicolaou General Hospital

Thessaloniki, GreeceOpen George Papanicolaou General Hospital in Google Maps

Ospedale Bassini

Balsamo Cinisello, Italy

Universita Degli Studi di Bari Policlinico

Bari, Italy

Spedali Civili

Brescia, Italy
Suspended85 Study Centers