Randomized, phase III trial comparing adjuvant gemcitabine (Gem) versus Gem plus chemoradiation (CCRT) in curatively resected pancreatic ductal adenocarcinoma (PDAC): A Taiwan cooperative oncology group study
- Chang, HJ
DOIAbstract
[[abstract]]Background: Adjuvant chemotherapy is the standard of care for PDAC after curative intent surgery. Current study aims to evaluate the role of additional consolidation CCRT to 6-month adjuvant Gem therapy in resectable PDAC. Methods: Patients with R0/R1 resected PDAC, and negative CT finding within 2 weeks and CA-19.9 <2.5x NUL within one week before registration were eligible. Enrolled patients were stratified by section margin, tumor size and lymph node status then randomized to have either 6 cycles of weekly gemcitabine, day 1, 8 and 15 every 28 days (Arm 1) or 3 cycles of weekly Gem followed by Gem-based CCRT and then another 3 cycles of Gem (Arm 2). The treatment should be initiated within 8 weeks after surgery. The primary e...
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