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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003216 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma |
Estimated Enrollment: | 518 |
Study Start Date: | July 1998 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal involvement (yes vs no), tumor diameter (less than 3 cm vs 3 cm or greater), and surgical margins (negative vs positive vs unknown).
Patients are randomized to one of two treatment arms.
PROJECTED ACCRUAL: A total of 518 patients will be accrued for this study within 8.6 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Able to maintain adequate nutrition (at least 1,500 calories/day)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | William F. Regine, MD | Lucille P. Markey Cancer Center at University of Kentucky |
Study Chair: | Al B. Benson, MD, FACP | Robert H. Lurie Cancer Center |
Study Chair: | John S. MacDonald, MD | St. Vincent's Comprehensive Cancer Center - Manhattan |
Study ID Numbers: | CDR0000066076, RTOG-9704, E-R9704, SWOG-R9704 |
Study First Received: | November 1, 1999 |
Last Updated: | March 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00003216 History of Changes |
Health Authority: | United States: Federal Government |
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Adjuvants, Immunologic Endocrine System Diseases Antiviral Agents Immunosuppressive Agents Pancrelipase |
Digestive System Diseases Radiation-Sensitizing Agents Fluorouracil Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Fluorouracil Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |