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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064207
• Other study ID #: EORTC-40013-22012
• Secondary ID: EORTC-40013EORTC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 8, 2003
• Last updated: September 20, 2012
• Start date: May 2003

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	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	Liege
Belgium	Algemeen Ziekenhuis Sint-Augustinus	Wilrijk
France	Centre Hospitalier d'Abbeville	Abbeville
France	Centre Hospitalier d'Annecy	Annecy
France	Hopital Duffaut	Avignon
France	Institut Sainte Catherine	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-Jallieu
France	CHU de Caen	Caen
France	CHR Clermont Ferrand, Hotel dieu	Clermont-Ferrand
France	Hopital Beaujon	Clichy
France	Louis Mourier Hospital	Colombes Cedex
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
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	Centre Leon Berard	Lyon
France	Clinique Saint Jean	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	Nimes
France	CHU Pitie-Salpetriere	Paris
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Cochin	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	C.H.G. De Pau	Pau
France	Centre Hospitalier Lyon Sud	Pierre Benite
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	Vandoeuvre-les-Nancy
Germany	Charite - Campus Charite Mitte	Berlin
Germany	Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch	Berlin
Germany	Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Johannes Gutenberg University	Mainz
Germany	Munich Oncologic Practice at Elisenhof	Munich
Israel	Rambam Medical Center	Haifa
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Switzerland	Hopital Cantonal Universitaire de Geneve	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Federation Francophone de Cancerologie Digestive

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Israel,  Netherlands,  Switzerland, 

References & Publications (2)

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 Cli

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II			No
Primary	Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II			Yes
Primary	Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II			Yes
Primary	Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III			No
Secondary	Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter			No
Secondary	Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter			Yes
Secondary	Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter			Yes
Secondary	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			No