Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
NCT ID: NCT00064207
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
97 participants
INTERVENTIONAL
2003-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gemcitabine hydrochloride
adjuvant therapy
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federation Francophone de Cancerologie Digestive
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Luc Van Laethem, MD, PhD
Role: STUDY_CHAIR
Erasme University Hospital
Volker G. Budach, MD, PhD
Role: STUDY_CHAIR
Charite University, Berlin, Germany
Pascal Hammel, MD, PhD
Role: STUDY_CHAIR
Hopital Beaujon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital Universitaire Erasme
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Hopital de Jolimont
Haine-Saint-Paul, , Belgium
Cazk Groeninghe - Campus St-Niklaas
Kortrijk, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , Belgium
Centre Hospitalier d'Abbeville
Abbeville, , France
Centre Hospitalier d'Annecy
Annecy, , France
Institut Sainte Catherine
Avignon, , France
Hopital Duffaut
Avignon, , France
C.H.G. Beauvais
Beauvais, , France
Centre Hospitalier de Blois
Blois, , France
Clinique Tivoli
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Boucher, , France
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne-Billancourt, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
Centre Hospitalier Pierre Oudot
Bourgoin, , France
CHU de Caen
Caen, , France
CHR Clermont Ferrand, Hotel dieu
Clermont-Ferrand, , France
Hopital Beaujon
Clichy, , France
Louis Mourier Hospital
Colombes, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Centre Hospitalier de Dax
Dax, , France
Hopital Du Bocage
Dijon, , France
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Clinique Victor Hugo
Le Mans, , France
Hopital Robert Boulin
Libourne, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Clinique Saint Jean
Lyon, , France
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nîmes, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
Hopital Saint Antoine
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Cochin
Paris, , France
Hopital Tenon
Paris, , France
C.H.G. De Pau
Pau, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
Hopital Charles Nicolle
Rouen, , France
Centre Paul Strauss
Strasbourg, , France
Hopital Universitaire Hautepierre
Strasbourg, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Charite - Campus Charite Mitte
Berlin, , Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Johannes Gutenberg University
Mainz, , Germany
Munich Oncologic Practice at Elisenhof
Munich, , Germany
Rambam Medical Center
Haifa, , Israel
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Hopital Cantonal Universitaire de Geneve
Geneva, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-40013
Identifier Type: -
Identifier Source: secondary_id
EORTC-22012
Identifier Type: -
Identifier Source: secondary_id
FFCD-0304
Identifier Type: -
Identifier Source: secondary_id
EU-20540
Identifier Type: -
Identifier Source: secondary_id
EORTC-40013-22012
Identifier Type: -
Identifier Source: org_study_id