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

NCT00064207 | Completed Phase 2

• 5 other identifiers: EORTC-40013-22012EORTC-40013EORTC-22012FFCD-0304EU-20540
• Study Type: interventional
• Target: 97
• Locations: 6 countries
• Sites: 59

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• 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

Interventions

gemcitabine hydrochloride DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Federation Francophone de Cancerologie Digestive: collaborator

Study Sites (59)

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Cazk Groeninghe - Campus St-Niklaas

Kortrijk, B-8500, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Centre Hospitalier d'Abbeville

Abbeville, 80101, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Centre Hospitalier de Blois

Blois, 41016, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Polyclinique Bordeaux Nord Aquitaine

Boucher, 33300, France

Location

Centre Hospitalier Universitaire Ambroise Pare - Boulogne

Boulogne-Billancourt, F-92104, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

Centre Hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

CHU de Caen

Caen, 14033, France

Location

CHR Clermont Ferrand, Hotel dieu

Clermont-Ferrand, 63003, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Louis Mourier Hospital

Colombes, 92701, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Centre Hospitalier de Dax

Dax, 40107, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre Hospitalier Intercommunal St. Aubin les Elbeuf

Elbeuf, 76503, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

Nîmes, 30029, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Tenon

Paris, 75970, France

Location

C.H.G. De Pau

Pau, 64000, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Berlin, D-13122, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, D-40225, Germany

Location

Johannes Gutenberg University

Mainz, D-55101, Germany

Location

Munich Oncologic Practice at Elisenhof

Munich, D-80335, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 20837948 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Jean-Luc Van Laethem, MD, PhD

  Erasme University Hospital

  STUDY CHAIR

• Volker G. Budach, MD, PhD

  Charite University, Berlin, Germany

  STUDY CHAIR

• Pascal Hammel, MD, PhD

  Hopital Beaujon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: May 1, 2003
• Primary Completion: January 1, 2007
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

CH (1); FR (45); DE (5); BE (6); IL (1); NL (1)