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

NCT00058201 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2013-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

fluorouracil

Given IV

DRUG

gemcitabine hydrochloride

Given IV

DRUG

leucovorin calcium

Given IV

OTHER

clinical observation

No intervention

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • Royal Liverpool University Hospital

    lead OTHER_GOV

Principal Investigators

  • John P. Neoptolemos, MD · Royal Liverpool University Hospital

  • Malcolm J. Moore, MD · Princess Margaret Hospital, Canada

  • R. Padbury · Flinders Medical Centre

  • David Goldstein, MD · Institute of Oncology at Prince of Wales Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2008-04-30
Completion
2010-09-30

Countries

  • Australia
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00058201 on ClinicalTrials.gov