Completed

Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid

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What is being tested

fluorouracil

+ leucovorin calcium

+ adjuvant therapy

DrugProcedure
Who is being recruted

Colonic Diseases+9

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorRobert Roessle Klinik
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection. Compare the safety of these regimens in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses. Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses. OR Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks. Treatment repeats every 7 weeks for 3 courses. OR Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses. Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death. PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.

NCT00004150
Principal SponsorRobert Roessle Klinik
Last updated: November 6, 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.

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.

Over 18 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 NeoplasmsColorectal Neoplasms

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon Must have had curative radical resection within 56 days prior to study No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No severe coronary heart disease No New York Heart Association class III or IV heart failure Other: No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No uncontrolled infection No other severe disease No known allergy to leucovorin calcium No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer) Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for colon cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for colon cancer Surgery: See Disease Characteristics Other: No other concurrent systemic anticancer therapy

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

Ziekenhuis Network Antwerpen Middelheim

Antwerp, BelgiumOpen Ziekenhuis Network Antwerpen Middelheim in Google Maps

Institut Jules Bordet

Brussels, Belgium

Hopital Universitaire Erasme

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium
Completed85 Study Centers