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

20. september 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

97

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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

Sekundære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Samarbejdspartnere

Federation Francophone de Cancerologie Digestive

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2003

Primær færdiggørelse (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først indsendt

8. juli 2003

Først indsendt, der opfyldte QC-kriterier

8. juli 2003

Først opslået (Skøn)

9. juli 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. september 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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