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Phase III Adjuvant Chemotherapy with 5-Fluorouracil and Radiotherapy Following Curative Resection for Pancreatic Adenocarcinoma
Basic Trial Information
Objectives I. Determine whether postoperative adjuvant therapy with 5-fluorouracil and supervoltage irradiation can increase the disease-free interval and length of survival in patients with curable pancreatic adenocarcinoma of the ductal, acinar, and undifferentiated variety. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically confirmed acinar, ductal, or undifferentiated pancreatic adenocarcinoma who have undergone curative resection of the primary pancreatic neoplasm as well as all recognizable regional, nodal, and peritoneal involvement (Whipple procedure or total pancreatectomy). Prior chemotherapy within one year of entry excludes, and there may be no prior radiotherapy to the field employed in this study. Patients must have adequate oral nutrition and be able to maintain a stable weight for two weeks prior to randomization. Hematocrit less than 30, BUN above 25, bilirubin above 3.0, SGOT above 100, and alkaline phosphatase greater than 25% of normal exclude; WBC and platelet counts must be at least 4,000 and 150,000/cumm, respectively. Coexistent malignant disease, excluding cutaneous epitheliomas, excludes. There may be no active and significant coexistent disease that would prohibit therapy on this protocol. Per Addendum 1, patients who had a subtotal pancreatectomy due to vascular anastomosis are eligible; elevated alkaline phosphatase, SGOT and bilirubin levels are no longer contraindications to patient selection. Expected Enrollment Approximately 10 patients per year to be entered for a minimum of 150 total patients. Protocol closed August 1984. Outline Randomized study. Patients are randomized 4 to 10 weeks following resection. Arm I: Control. No further therapy. (Arm closed per Addendum 2, June 1982.) Arm II: Radiotherapy plus Single-agent Chemotherapy. Tumor irradiation using supervoltage equipment; plus 5-Fluorouracil, 5-FU, NSC-19893.Published Results Further evidence of effective adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer. Gastrointestinal Tumor Study Group. Cancer 59 (12): 2006-10, 1987.[PUBMED Abstract] Kalser MH, Ellenberg SS: Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 120 (8): 899-903, 1985.[PUBMED Abstract] Related PublicationsSteinberg SM, Kalser MH, Douglass HO, et al.: Experience of patients registered to therapy for adjuvant pancreatic cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-325, 84, 1985. Trial Lead Organizations Gastrointestinal Tumor Study 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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