- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00064207
Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 3
Kontakte und Standorte
Studienorte
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Brussels, Belgien, 1070
- Hopital Universitaire Erasme
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Ghent, Belgien, B-9000
- Universitair Ziekenhuis Gent
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Haine Saint Paul, Belgien, 7100
- Hopital de Jolimont
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Kortrijk, Belgien, B-8500
- Cazk Groeninghe - Campus St-Niklaas
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Liege, Belgien, B-4000
- CHU Liege - Domaine Universitaire du Sart Tilman
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Wilrijk, Belgien, 2610
- Algemeen Ziekenhuis Sint-Augustinus
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Berlin, Deutschland, D-10117
- Charité - Campus Charité Mitte
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Berlin, Deutschland, D-13122
- Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
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Duesseldorf, Deutschland, D-40225
- Universitaetsklinikum Duesseldorf
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Mainz, Deutschland, D-55101
- Johannes Gutenberg University
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Munich, Deutschland, D-80335
- Munich Oncologic Practice at Elisenhof
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Abbeville, Frankreich, 80101
- Centre Hospitalier d'Abbeville
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Annecy, Frankreich, 74011 Cedex
- Centre Hospitalier D'annecy
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Avignon, Frankreich, 84902
- Hopital Duffaut
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Avignon, Frankreich, 84082
- Institut Sainte Catherine
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Beauvais, Frankreich, 60021
- C.H.G. Beauvais
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Blois, Frankreich, 41016
- Centre Hospitalier de Blois
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Bordeaux, Frankreich, F-33000
- Clinique Tivoli
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Boucher, Frankreich, 33300
- Polyclinique Bordeaux Nord Aquitaine
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Boulogne Billancourt, Frankreich, F-92104
- Centre Hospitalier Universitaire Ambroise Pare - Boulogne
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Boulogne Sur Mer, Frankreich, 62200
- Centre Hospitalier Docteur Duchenne
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Bourgoin-Jallieu, Frankreich, 38300
- Centre hospitalier Pierre Oudot
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Caen, Frankreich, 14033
- CHU de Caen
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Clermont-Ferrand, Frankreich, 63003
- CHR Clermont Ferrand, Hotel Dieu
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Clichy, Frankreich, 92118
- Hopital Beaujon
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Colombes Cedex, Frankreich, 92701
- Louis Mourier Hospital
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Creteil, Frankreich, 94010
- Centre Hospitalier Universitaire Henri Mondor
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Dax, Frankreich, 40107
- Centre Hospitalier de Dax
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Dijon, Frankreich, 21034
- Hopital Du Bocage
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Elbeuf, Frankreich, 76503
- Centre Hospitalier Intercommunal St. Aubin les Elbeuf
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Grenoble, Frankreich, 38043
- CHU de Grenoble - Hopital de la Tronche
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La Roche Sur Yon, Frankreich, F-85025
- Centre Hospitalier departemental
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Le Mans, Frankreich, F-72000
- Clinique Victor Hugo
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Libourne, Frankreich, 33500
- Hôpital Robert Boulin
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Limoges, Frankreich, 87042
- Centre Hospital Regional Universitaire de Limoges
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Lyon, Frankreich, 69008
- Clinique Saint Jean
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Lyon, Frankreich, 69373
- Centre Leon Berard
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Marseille, Frankreich, 13385
- CHU de la Timone
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Mont-de-Marsan, Frankreich, 40000
- Centre Hospitalier General de Mont de Marsan
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Montpellier, Frankreich, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Mulhouse, Frankreich, 68051
- Centre Hospitalier de Mulhouse
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Nimes, Frankreich, 30029
- C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
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Paris, Frankreich, 75015
- Hopital Europeen Georges Pompidou
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Paris, Frankreich, 75018
- Hôpital Bichat - Claude Bernard
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Paris, Frankreich, 75651
- CHU Pitié-Salpêtrière
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Paris, Frankreich, 75674
- Hopital Cochin
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Paris, Frankreich, 75970
- Hopital Tenon
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Paris, Frankreich, 75571
- Hopital Saint Antoine
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Pau, Frankreich, 64000
- C.H.G. De Pau
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Pierre Benite, Frankreich, 69495
- Centre Hospitalier Lyon Sud
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Poitiers, Frankreich, 86021
- CHU Poitiers
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Rouen, Frankreich, 76031
- Hopital Charles Nicolle
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Strasbourg, Frankreich, 67098
- Hopital Universitaire Hautepierre
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Strasbourg, Frankreich, 67065
- Centre Paul Strauss
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Tours, Frankreich, 37044
- Centre Hospitalier Universitaire Bretonneau de Tours
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Vandoeuvre-les-Nancy, Frankreich, 54511
- Centre Alexis Vautrin
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Haifa, Israel, 31096
- Rambam Medical Center
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Amsterdam, Niederlande, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Geneva, Schweiz, CH-1211
- Hopital Cantonal Universitaire de Geneve
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
---|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter
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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
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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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Volker G. Budach, MD, PhD, Charite University, Berlin, Germany
- Studienstuhl: Pascal Hammel, MD, PhD, Hopital Beaujon
- Studienstuhl: Jean-Luc Van Laethem, MD, PhD, Erasme University Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Erkrankungen des endokrinen Systems
- Neoplasmen des Verdauungssystems
- Neoplasmen der endokrinen Drüse
- Erkrankungen der Bauchspeicheldrüse
- Neoplasmen der Bauchspeicheldrüse
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Gemcitabin
Andere Studien-ID-Nummern
- EORTC-40013-22012
- EORTC-40013
- EORTC-22012
- FFCD-0304
- EU-20540
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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