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Phase III Radiotherapy with vs without Radiation Sensitizers (5-FU/MITO) for Locally Unresectable Stage I/II/III Pancreatic Carcinoma
Basic Trial Information
Objectives I. Test the feasibility and efficacy (relapse-free survival rates, length of remission, relapse patterns, survival) of radiation with or without radiation sensitizers (5-fluorouracil/mitomycin-C) as a therapeutic modality for unresected carcinoma of the pancreas. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients of any age with Stage I, II, or III pancreatic carcinoma or with biopsy-proven ductal adenocarcinoma Grades 1-3, provided they have had an exploratory laparotomy. Tumors must not be larger than 15 cm in any dimension. The tumor must be unresectable. Patients must have a performance status of 0, 1, or 2 and adequate bone marrow function and oral nutrition (at least 1,200 calories/day). Prior abdominal radiotherapy and prior systemic therapy are not allowed. Patients must be at least 10 days but no more than 6 weeks past major abdominal surgery. The lesion should be outlined with clips if possible (relaparotomy to place clips is permissible). Patients without clips are eligible provided the CT scan permits adequate tumor definition for precision high-dose radiotherapy. Patients with active infections, concurrent cancer (except skin cancer), or other disease processes that would prohibit protocol treatment are not eligible. Expected Enrollment A minimum of 105 evaluable patients is required. Outline Randomized study. Arm I: Radiotherapy. Irradiation of the pancreas using megavoltage equipment. Arm II: Radiotherapy plus Sensitizers. Pancreatic irradiation plus 5-Fluorouracil, 5-FU, NSC-19893; Mitomycin-C, MITO, NSC-26980.Published Results Cohen SJ, Dobelbower R Jr, Lipsitz S, et al.: A randomized phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern Cooperative Oncology Group study E8282. Int J Radiat Oncol Biol Phys 62 (5): 1345-50, 2005.[PUBMED Abstract] Trial Lead Organizations Eastern Cooperative Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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