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

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ClinicalTrials.gov Identifier: NCT00058201
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : December 18, 2013
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Other: clinical observation Phase 3

Detailed Description:



  • 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.


  • 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1030 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: European Study Group For Pancreatic Cancer - Trial 3
Study Start Date : July 2001
Primary Completion Date : April 2008
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm I
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Experimental: Arm II
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
Drug: gemcitabine hydrochloride
Given IV
No Intervention: Arm III
Patients undergo observation.
Other: clinical observation
No intervention

Outcome Measures

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Toxicity as measured by NCI CTC v2.0
  2. 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
  3. Survival rate at 2 and 5 years

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • More than 3 months


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • No neoadjuvant chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics
  • Recovered from prior resection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058201

  Hide Study Locations
Australia, New South Wales
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Research Institute at Queen's University
Kingston, Ontario, Canada, K7L 3N6
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Czech Republic
Institute for Clinical and Experimental Medicine
Preha 4, Czech Republic, 14021
Tampere University Hospital
Tampere, Finland, 33521
Hopital Tenon
Paris, France, 75970
Universitaets-Kinderklinik Heidelberg
Heidelberg, Germany, D-69120
Agia Olga Hospital
Athens, Greece, G-15233
Petz Aladar County Hospital
Gydr, Hungary, h-9024
Policlinico Borgo Roma
Verona, Italy, 37134
Kyoto University Hospital
Kyoto, Japan, 606-8507
Uppsala University Hospital
Uppsala, Sweden, S-75185
Inselspital Bern
Bern, Switzerland, CH-3010
United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L69 3GA
Sponsors and Collaborators
Royal Liverpool University Hospital
NCIC Clinical Trials Group
Australasian Gastro-Intestinal Trials Group
Study Chair: John P. Neoptolemos, MD Royal Liverpool University Hospital
Study Chair: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
OverallOfficial: R. Padbury Flinders Medical Centre
OverallOfficial: David Goldstein, MD Institute of Oncology at Prince of Wales Hospital
More Information

ClinicalTrials.gov Identifier: NCT00058201     History of Changes
Other Study ID Numbers: CDR0000287023
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: May 2008

Keywords provided by National Cancer Institute (NCI):
acinar cell adenocarcinoma of the pancreas
duct cell adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances