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Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer

NCT00064207 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2012-09-24

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.

Conditions

Interventions

DRUG

gemcitabine hydrochloride

PROCEDURE

adjuvant therapy

RADIATION

radiation therapy

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Jean-Luc Van Laethem, MD, PhD · Erasme University Hospital

  • Volker G. Budach, MD, PhD · Charite University, Berlin, Germany

  • Pascal Hammel, MD, PhD · Hopital Beaujon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2007-01-31

Countries

  • Belgium
  • France
  • Germany
  • Israel
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

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 NCT00064207 on ClinicalTrials.gov