Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	RLUH-NCRI-ESPAC-3(V2) EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3, NCT00058201, PA2

Objectives

Primary

1. 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 overall survival, in patients with completely resected pancreatic cancer.

Secondary

1. Compare the toxicity of these regimens in these patients.
2. Compare the quality of life and 5-year survival of patients treated with these regimens.

Entry Criteria

Disease 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

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

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

Expected Enrollment

A total of 1,030 patients with pancreatic adenocarcinoma (515 per arms I and II) will be accrued for this study.

Outcomes

Overall survival

Toxicity as measured by NCI CTC v2.0
Quality of life as measured by EORTC QLQ C-30 and ESPAC-QLQ at 3, 6, and 12 months, and then annually for 5 years
Survival rate at 2 and 5 years

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.

Trial Contact Information

Trial Lead Organizations

Royal Liverpool University Hospital

John Neoptolemos, MD, Protocol chair		Ph: 44-151-706-4175 Email: j.p.neoptolemos@liv.ac.uk

NCIC-Clinical Trials Group

Malcolm Moore, MD, Protocol chair		Ph: 416-946-2263

Australasian Gastro-Intestinal Trials Group

R. Padbury, Study coordinator		Ph: 61-8-8204-4523
David Goldstein, MD, Study coordinator		Ph: 61-2-9382-2577 Email: d.goldstein@unsw.edu.au

Registry Information
Official Title		European Study Group For Pancreatic Cancer - Trial 3
Trial Start Date		2001-07-07
Trial Completion Date		2008-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00058201
Date Submitted to PDQ		2003-02-21
Information Last Verified		2008-05-20