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Principal Name   Harvey Zimbler, MD
Contact Name   Gloria Gero
Phone   (413) 496-8205
Alternate Phone   (413) 443-6000
Fax   (413) 443-2203
Title   RTOG 0848- " A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma"
Description   Primary objective:
1)To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy improves survival as compared to gemcitabine alone following R0 or R1 resection of head of pacreas adenocarcionoma (including adenocarcinoma of the head, neck, and uncinate process)
2) To determine whether the use of concurrent fluorophyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy further enhances sruvival for such patients who are without evidence of progressive disease afaer 5 cycles of gemcitabine based chemotherapy.
Treatment   Oncology
Inclusion/Notes   Eligibility:
-Histologic proof of primary head of pancreas invasive adenocarcinoma managed with potentially curative resection (i.e., removal of all gross tumore) involving a classic pancreataicoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy.
-Patients will be staged according to the 6th edition AJCC stagin system with pathologic stage T1-3, N0-1, M-0 being eligible.
-over age 18 years
-Performance status 0-1
-before starting therapy patient should be able to maintain adequate oral nutrition of more than 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
-post resection serum CA19-9 must be less than 180 units/mL within 21 days of registration on study

Ineligibility:
-patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell(neuroendocrine) tumors, cystadenomas, cystaadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas
-patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
-prior systemkic chemotherapy for pancreas cancer
-prior radiotherapy to the region of the study cancer
-previous history of invasive malignancy
Status   accruing
Current Trial Type   treatment


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