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

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: gemcitabine hydrochloride; Other: clinical observation; Drug: fluorouracil; Drug: leucovorin calcium

• Registration Number: NCT00058201
• Lead Sponsor: Royal Liverpool University Hospital

Brief Summary

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.

Detailed Description

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 overall survival, 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.

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.

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

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2003-04-07
• Study First Submitted QC: 2003-04-08
• Study First Posted: 2003-04-09
• Primary Completion: 2008-04
• Status Verified: 2008-05
• Study Completion: 2010-09
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1030

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	leucovorin calcium	Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
Arm II	gemcitabine hydrochloride	Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
Arm III	clinical observation	Patients undergo observation.
Arm I	fluorouracil	Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (27)

Institute of Oncology at Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Policlinico Borgo Roma; 🇮🇹 Verona, Italy

British Columbia Cancer Agency - Vancouver Island Centre; 🇨🇦 Victoria, British Columbia, Canada

Cross Cancer Institute at University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Cancer Research Institute at Queen's University; 🇨🇦 Kingston, Ontario, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Health Centre - Toronto; 🇨🇦 Toronto, Ontario, Canada

London Regional Cancer Program at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Ottawa Hospital Regional Cancer Centre - General Campus; 🇨🇦 Ottawa, Ontario, Canada

Hopital Charles Lemoyne; 🇨🇦 Greenfield Park, Quebec, Canada

Institute for Clinical and Experimental Medicine; 🇨🇿 Preha 4, Czech Republic

McGill Cancer Centre at McGill University; 🇨🇦 Montreal, Quebec, Canada

Tampere University Hospital; 🇫🇮 Tampere, Finland

Hopital Tenon; 🇫🇷 Paris, France

Universitaets-Kinderklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Petz Aladar County Hospital; 🇭🇺 Gydr, Hungary

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Agia Olga Hospital; 🇬🇷 Athens, Greece

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Inselspital Bern; 🇨🇭 Bern, Switzerland

Cancer Centre of Southeastern Ontario at Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Edmond Odette Cancer Centre at Sunnybrook; 🇨🇦 Toronto, Ontario, Canada

British Columbia Cancer Agency - Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

Royal Liverpool University Hospital; 🇬🇧 Liverpool, England, United Kingdom