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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Bukspottskörtelcancer

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

Fas

Fas 2
Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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
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
Nederländerna
- - Amsterdam, Nederländerna, 1105 AZ
    - Academisch Medisch Centrum at University of Amsterdam
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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Randomiserad

Vad mäter studien?

Primära resultatmått

Resultatmått
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

Sekundära resultatmått

Resultatmått
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Samarbetspartners

Federation Francophone de Cancerologie Digestive

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2003

Primärt slutförande (Faktisk)

1 januari 2007

Studieregistreringsdatum

Först inskickad

8 juli 2003

Först inskickad som uppfyllde QC-kriterierna