Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	PETACC-2 EORTC-40963, FFCD-PETACC-2, GETTD-PETACC-2, NCT00004150

Objectives

1. 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.
2. Compare the safety of these regimens in this patient population.

Entry 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)

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.

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.

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.

Fensterer H, Radlwimmer B, Sträter J, et al.: Matrix-comparative genomic hybridization from multicenter formalin-fixed paraffin-embedded colorectal cancer tissue blocks. BMC Cancer 7: 58, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

Claus-Henning Koehne, MD, Study coordinator		Ph: 49-441-403-2611 Email: onkologie@klinikum-oldenburg.de

European Organization for Research and Treatment of Cancer

G. Leam, Study coordinator		Ph: 31-475-382-866

Federation Francophone de Cancerologie Digestive

Laurent Bedenne, MD, Study coordinator		Ph: 33-3-8029-3750 Email: lbedenne@u-bourgogne.fr

Grupo Espanol Tratamiento Tumores Digestivos

Alfredo Carrato-Mena, MD, Protocol chair		Ph: 34-96-667-9359 Email: carrato_alf@gva.es

Registry Information
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
Trial Start Date		1999-03-03
Registered in ClinicalTrials.gov		NCT00004150
Date Submitted to PDQ		1999-10-08
Information Last Verified		2001-02-16

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