High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
Federation Francophone de Cancerologie Digestive
Grupo Espanol Tratamiento Tumores Digestivos
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004150
First received: December 10, 1999
Last updated: February 6, 2009
Last verified: February 2001
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.
PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | March 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004150
Show 85 Study Locations
Show 85 Study LocationsSponsors and Collaborators
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
European Organisation for Research and Treatment of Cancer - EORTC
Federation Francophone de Cancerologie Digestive
Grupo Espanol Tratamiento Tumores Digestivos
Investigators
| Investigator: | Claus-Henning Koehne, MD | Klinikum Oldenburg |
| Investigator: | G. Leam | Saint Laurentius Ziekenhuis |
| Investigator: | Laurent Bedenne, MD | Hopital Du Bocage |
| Study Chair: | Alfredo Carrato-Mena, MD | Hospital Universitario de Elche |
More Information
Additional Information:
Publications:
Carrato A, Köhne C, Bedenne L, et al.: Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: preliminary analysis of the PETACC-2-study. [Abstract] J Clin Oncol 24 (Suppl 18): A-3563, 2006.
| ClinicalTrials.gov Identifier: | NCT00004150 History of Changes |
| Other Study ID Numbers: | CDR0000067383, PETACC-2, EORTC-40963, FFCD-PETACC-2, GETTD-PETACC-2 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III colon cancer adenocarcinoma of the colon mucinous adenocarcinoma of the colon |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Adjuvants, Immunologic Fluorouracil Leucovorin |
Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 19, 2013