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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Phase II:

  • Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine vs gemcitabine alone after prior curative resection in patients with pancreatic head adenocarcinoma.
  • Compare the tolerability of these regimens, in terms of acute and late toxicity, in these patients.

Phase III:

  • Compare the disease-free and overall survival of patients treated with these regimens .
  • Compare the quality of life of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Determine the sites of recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG/WHO performance status (0-1 vs 2), participating center, and N stage (N0 vs N1 vs NX). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Within 8 weeks after prior surgical resection, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses.

Patients then receive additional gemcitabine IV over 30 minutes on days 57, 64, 71, 78, 85, and 92. Beginning on day 57, patients also undergo radiotherapy once daily, 5 days a week, for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 4 courses.

Quality of life (QOL) is assessed in both arms, according to the following schedules:

  • Arm I: QOL is assessed at baseline; at 3 weeks after the beginning of chemoradiotherapy; after the completion of chemoradiotherapy; every 3 months for 2 years; and then every 6 months for 1 year.
  • Arm II: QOL is assessed at baseline; at 12 weeks; at 16 weeks; every 3 months for 2 years; and then every 6 months for 1 year.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 538 patients (269 per treatment arm) will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Haine Saint Paul, Belgium, 7100
        • Hopital de Jolimont
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus St-Niklaas
      • Liege, Belgium, B-4000
        • CHU Liege - Domaine Universitaire du Sart Tilman
      • Wilrijk, Belgium, 2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • France
      • Abbeville, France, 80101
        • Centre Hospitalier d'Abbeville
      • Annecy, France, 74011 Cedex
        • Centre Hospitalier d'Annecy
      • Avignon, France, 84902
        • Hopital Duffaut
      • Avignon, France, 84082
        • Institut Sainte Catherine
      • Beauvais, France, 60021
        • C.H.G. Beauvais
      • Blois, France, 41016
        • Centre Hospitalier de Blois
      • Bordeaux, France, F-33000
        • Clinique Tivoli
      • Boucher, France, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Boulogne Billancourt, France, F-92104
        • Centre Hospitalier Universitaire Ambroise Pare - Boulogne
      • Boulogne Sur Mer, France, 62200
        • Centre Hospitalier Docteur Duchenne
      • Bourgoin-Jallieu, France, 38300
        • Centre Hospitalier Pierre Oudot
      • Caen, France, 14033
        • CHU De Caen
      • Clermont-Ferrand, France, 63003
        • CHR Clermont Ferrand, Hotel Dieu
      • Clichy, France, 92118
        • Hôpital Beaujon
      • Colombes Cedex, France, 92701
        • Louis Mourier Hospital
      • Creteil, France, 94010
        • Centre Hospitalier Universitaire Henri Mondor
      • Dax, France, 40107
        • Centre Hospitalier de Dax
      • Dijon, France, 21034
        • Hôpital du Bocage
      • Elbeuf, France, 76503
        • Centre Hospitalier Intercommunal St. Aubin les Elbeuf
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • La Roche Sur Yon, France, F-85025
        • Centre Hospitalier Departemental
      • Le Mans, France, F-72000
        • Clinique Victor Hugo
      • Libourne, France, 33500
        • Hôpital Robert Boulin
      • Limoges, France, 87042
        • Centre Hospital Regional Universitaire de Limoges
      • Lyon, France, 69008
        • Clinique Saint Jean
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13385
        • CHU de la Timone
      • Mont-de-Marsan, France, 40000
        • Centre Hospitalier General de Mont de Marsan
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Mulhouse, France, 68051
        • Centre Hospitalier de Mulhouse
      • Nimes, France, 30029
        • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75018
        • Hôpital Bichat - Claude Bernard
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Paris, France, 75674
        • Hôpital Cochin
      • Paris, France, 75970
        • Hopital Tenon
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Pau, France, 64000
        • C.H.G. De Pau
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHU Poitiers
      • Rouen, France, 76031
        • Hôpital Charles Nicolle
      • Strasbourg, France, 67098
        • Hopital Universitaire Hautepierre
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
  • Germany
      • Berlin, Germany, D-10117
        • Charité - Campus Charité Mitte
      • Berlin, Germany, D-13122
        • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
      • Duesseldorf, Germany, D-40225
        • Universitaetsklinikum Duesseldorf
      • Mainz, Germany, D-55101
        • Johannes Gutenberg University
      • Munich, Germany, D-80335
        • Munich Oncologic Practice at Elisenhof
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
  • Switzerland
      • Geneva, Switzerland, CH-1211
        • Hôpital Cantonal Universitaire de Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic head adenocarcinoma

  • Prior pancreaticoduodenectomy required

    • Documented histological examination of surgical margins (R0), including retroperitoneal margin
    • Performed within the past 8 weeks
  • Any number of lymph nodes (less than 10 OR 10 or more) allowed
  • No periampullary cancer

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 3,500/mm^3
  • Platelet count greater than 150,000/mm^3
  • Hemoglobin greater than 9.0 g/dL

Hepatic

  • Bilirubin less than 1.5 times normal
  • AST and ALT less than 3.0 times normal

Renal

  • Creatinine less than 1.2 mg/dL

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No other concurrent anticancer agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II
Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II
Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III

Secondary Outcome Measures

Outcome Measure
Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter
Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter
Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) v3.0 and EORTC QLQ PAN-26 every 3 months in years 1-2 and every 6 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Federation Francophone de Cancerologie Digestive

Investigators

  • Study Chair: Volker G. Budach, MD, PhD, Charite University, Berlin, Germany
  • Study Chair: Pascal Hammel, MD, PhD, Hôpital Beaujon
  • Study Chair: Jean-Luc Van Laethem, MD, PhD, Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 8, 2003

First Submitted That Met QC Criteria

July 8, 2003

First Posted (Estimate)

July 9, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-40013-22012
  • EORTC-40013
  • EORTC-22012
  • FFCD-0304
  • EU-20540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on radiation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe