AzTrials
AzTrials

Pancreatic CancerPhase 2/3NCT00064207

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

A Phase 2/3 study testing gemcitabine hydrochloride, adjuvant therapy and radiation therapy in people with Pancreatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 59 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
gemcitabine hydrochloride, adjuvant therapy and radiation therapy
Type of treatment
Surgery or procedure
How many people
97 participants
Where
59 sitesin 6 countries
Study dates
May 2003to Jan 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

59 sites in 6 countries.

59 sites in 6 countries

France45 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80101

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Institut Sainte Catherine

    Avignon, 84082

  • Hopital Duffaut

    Avignon, 84902

  • C.H.G. Beauvais

    Beauvais, 60021

  • Centre Hospitalier de Blois

    Blois, 41016

  • Clinique Tivoli

    Bordeaux, F-33000

  • Polyclinique Bordeaux Nord Aquitaine

    Boucher, 33300

  • Centre Hospitalier Universitaire Ambroise Pare - Boulogne

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • Centre Hospitalier Pierre Oudot

    Bourgoin, 38300

  • CHU de Caen

    Caen, 14033

  • CHR Clermont Ferrand, Hotel dieu

    Clermont-Ferrand, 63003

  • Hopital Beaujon

    Clichy, 92118

  • Louis Mourier Hospital

    Colombes, 92701

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • Centre Hospitalier de Dax

    Dax, 40107

  • Hopital Du Bocage

    Dijon, 21034

  • Centre Hospitalier Intercommunal St. Aubin les Elbeuf

    Elbeuf, 76503

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Hopital Robert Boulin

    Libourne, 33500

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Clinique Saint Jean

    Lyon, 69008

  • Centre Leon Berard

    Lyon, 69373

  • CHU de la Timone

    Marseille, 13385

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

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

    Montpellier, 34298

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

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

    Nîmes, 30029

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint Antoine

    Paris, 75571

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Cochin

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • C.H.G. De Pau

    Pau, 64000

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Poitiers

    Poitiers, 86021

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Belgium6 sites

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • Cazk Groeninghe - Campus St-Niklaas

    Kortrijk, B-8500

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Germany5 sites

  • Charite - Campus Charite Mitte

    Berlin, D-10117

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

    Berlin, D-13122

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, D-40225

  • Johannes Gutenberg University

    Mainz, D-55101

  • Munich Oncologic Practice at Elisenhof

    Munich, D-80335

Other trials in Germany

Israel1 site

  • Rambam Medical Center

    Haifa, 31096

Other trials in Israel

Netherlands1 site

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

Other trials in Netherlands

Switzerland1 site

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

Other trials in Switzerland

About this study

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

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.

Read the detailed 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.

Being tested
gemcitabine hydrochloride, adjuvant therapy, radiation therapy
Keywords
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II

  2. Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II

  3. Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II

  4. Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III

Secondary outcomes (4)

  1. Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter

  2. Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter

  3. Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter

  4. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study startMay 2003
  3. Primary completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064207
Sponsor's protocol ID
EORTC-40013-22012
Other IDs
EORTC-40013, EORTC-22012, FFCD-0304, EU-20540
Status last verified
Sep 2012
First submitted
8 Jul 2003
Last updated
24 Sep 2012
Results posted
No

Publications

  • 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.

    PubMed 20837948

  • Van Laethem JL, Mornex F, Azria D, et al.: Adjuvant gemcitabine alone versus gemcitabine-based chemoradiation after curative resection for pancreatic cancer: updated results of a randomized EORTC/FFCD/GERCOR phase II study (40013-22012/9203). [Abstract] J Clin Oncol 27 (Suppl 15): A-4527, 2009.

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing gemcitabine hydrochloride, adjuvant therapy and radiation therapy in people with Pancreatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 59 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in France, Belgium, Germany, Israel, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064207, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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