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Clinical Trials (PDQ®)

  • First Published: 3/24/2003
  • Last Modified: 7/18/2012

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Phase III Randomized Adjuvant Study of Gemcitabine Versus Fluorouracil and Leucovorin Calcium Versus Observation in Patients With Completely Resected Pancreatic Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

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

Alternate Title

Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overOtherRLUH-NCRI-ESPAC-3V2
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

1030

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

Outcomes

Primary Outcome(s)

Overall survival

Secondary Outcome(s)

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.

Published Results

Neoptolemos JP, Moore MJ, Cox TF, et al.: Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA 308 (2): 147-56, 2012.[PUBMED Abstract]

Neoptolemos JP, Stocken DD, Bassi C, et al.: Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA 304 (10): 1073-81, 2010.[PUBMED Abstract]

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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