Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer

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, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery.

PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.

Official Title

Phase III Randomized Adjuvant Study of Gemcitabine Versus Fluorouracil and Leucovorin Calcium Versus Observation in Patients With Completely Resected Pancreatic Cancer

Conditions

Study Type

Interventional

Study Design

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (ductal adenocarcinoma vs ampullary or other pancreatic malignancy), resection margin status, and participating country. Patients are randomized to 1 of 2 treatment arms. Randomization for patients with ampullary or other pancreatic malignancy includes an observation arm. Arm I: Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5. Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Arm III (patients with ampullary or other pancreatic malignancy only): Patients undergo observation. Treatment in arms I and II repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.Quality of life is assessed at baseline, 3, 6, and 12 months, and then annually for 5 years.Patients are followed every 3 months.

Further Details

OBJECTIVES:Primary:- Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium (vs observation only in patients with ampullary or other pancreatic malignancy), in terms of 2-year survival rate, in patients with completely resected pancreatic cancer. Secondary:- Compare the toxicity of these regimens in these patients. – Compare the quality of life and 5-year survival of patients treated with these regimens.

Study Start

Eligibility & Criteria

Ages Eligible for Study: 18 Years and aboveGenders Eligible for Study: Both CriteriaDISEASE CHARACTERISTICS:- Histologically confirmed ductal adenocarcinoma of the pancreas OR – Histologically confirmed diagnosis of 1 of the following types of cancer: – Acinar cell carcinoma or cystadenocarcinoma of the pancreas – Cancers of the periampullary region – Cancers of the intrapancreatic part of the bile duct – Periampullary cancers of uncertain origin – Complete macroscopic resection (R0 or R1 resection) – Histological examination of all resection margins required – No stage IVB disease – No evidence of malignant ascites – No liver or peritoneal metastases – No evidence of spread to other distant abdominal or extra-abdominal organs – No pancreatic lymphoma PATIENT CHARACTERISTICS:Age- 18 and over Performance status- WHO 0-2 Life expectancy- More than 3 months Hematopoietic- Not specified Hepatic- Not specified Renal- Not specified Other- Not pregnant Able to participate in long-term follow-up No other prior or concurrent malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No serious medical or psychological condition that would preclude study treatment PRIOR CONCURRENT THERAPY:Biologic therapy- Not specified Chemotherapy- No neoadjuvant chemotherapy, No other concurrent chemotherapy Endocrine therapy- Not specified Radiotherapy- Not specified Surgery- See Disease Characteristics, Recovered from prior resection

Total Enrolment

660 patients with pancreatic adenocarcinoma (330 per arms I and II) within 5 years.

Contact Details

Australia, New South WalesInstitute of Oncology at Prince of Wales Hospital, Randwick, New South Wales, 2031, Australia; Recruiting David Goldstein, MD 61-2-9382-2577 d.goldstein@unsw.edu.au NHMRC Clinical Trials Centre, Camperdown, New South Wales, 1450, Australia; Recruiting Anne McCall 61-02-952-5333 Australia, South AustraliaFlinder Medical Centres, Bedford Park, South Australia, 5042, Australia; Recruiting R. Padbury 61-8-8204-4523