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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Claus-Henning Koehne, MD

Investigator Affiliation:

Klinikum Oldenburg

Authority:

United States: Federal Government

Study ID:

CDR0000067383

NCT ID:

NCT00004150

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • mucinous adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms

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