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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Bukspyttkjertelkreft

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Fase 2
Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Samarbeidspartnere

Federation Francophone de Cancerologie Digestive

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Van Laethem JL, Hammel P, Mornex F, Azria D, Van Tienhoven G, Vergauwe P, Peeters M, Polus M, Praet M, Mauer M, Collette L, Budach V, Lutz M, Van Cutsem E, Haustermans K. Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study. J Clin Oncol. 2010 Oct 10;28(29):4450-6. doi: 10.1200/JCO.2010.30.3446. Epub 2010 Sep 13.
Van Laethem J, Van Cutsem E, Hammel P, et al.: Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer : feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). [Abstract] J Clin Oncol 26 (Suppl 15): A-4514, 2008.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2003

Primær fullføring (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først innsendt

8. juli 2003

Først innsendt som oppfylte QC-kriteriene