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| Sponsor: | Swiss Group for Clinical Cancer Research |
|---|---|
| Collaborator: |
Central European Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030732 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: capecitabine Drug: gemcitabine hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial |
| Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration.
Patients are followed every 9 weeks.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Austria | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna, Austria, A-1090 | |
| Israel | |
| Tel-Aviv Sourasky Medical Center | |
| Tel-Aviv, Israel, 64239 | |
| Italy | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Milan, Italy, 20133 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Switzerland | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Saint Claraspital AG | |
| Basel, Switzerland, CH-4016 | |
| Universitatsspital-Basel | |
| Basel, Switzerland, CH-4031 | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Spitalzentrum Biel | |
| Biel, Switzerland, CH-2501 | |
| Ratisches Kantons und Regionalspital | |
| Chur, Switzerland, CH-7000 | |
| Hopital Cantonal Universitaire de Geneve | |
| Geneva, Switzerland, CH-1211 | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| Institut Central des Hopitaux Valaisans | |
| Sion, Switzerland, CH1951 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Regionalspital | |
| Thun, Switzerland, 3600 | |
| City Hospital Triemli | |
| Zurich, Switzerland, 8063 | |
| UniversitaetsSpital | |
| Zurich, Switzerland, CH-8091 | |
| Oncology Institute of Southern Switzerland | |
| Zurich, Switzerland, CH-8091 | |
| Study Chair: | Richard Herrmann, MD | Universitaetsspital-Basel |
| Study Chair: | Werner Scheithauer, MD | Allgemeines Krankenhaus - Universitatskliniken |
More Information
| ClinicalTrials.gov Identifier: | NCT00030732 History of Changes |
| Other Study ID Numbers: | CDR0000069193, SWS-SAKK-44/00, CECOG/PAN-1.3.001, EU-20142 |
| Study First Received: | February 14, 2002 |
| Last Updated: | October 8, 2010 |
| Health Authority: | United States: Federal Government |
|
stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine Fluorouracil Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |