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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Federation Francophone de Cancerologie Digestive |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064207 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: radiation therapy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 538 |
Study Start Date: | May 2003 |
OBJECTIVES:
Phase II:
Phase III:
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.
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.
Quality of life (QOL) is assessed in both arms, according to the following schedules:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prior pancreaticoduodenectomy required
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Jean-Luc Van Laethem, MD, PhD | Hopital Universitaire Erasme |
Investigator: | Volker G. Budach, MD, PhD | Charite University, Berlin, Germany |
Study Chair: | P. Hammel, MD, PhD | Hopital Beaujon |
Study ID Numbers: | CDR0000310131, EORTC-40013, EORTC-22012, FFCD-0304, EU-20540 |
Study First Received: | July 8, 2003 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00064207 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the pancreas stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Endocrinopathy Gemcitabine Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |