At a glance
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Phase I Study of Proton Therapy in Adjuvant Pancreatic Cancer (Proton-PANC)
In Brief
A Phase 1 clinical trial evaluating mFOLFIRINOX and Proton beam radiation for Resected Pancreatic Adenocarcinoma. Completed, enrolled 9 participants across 1 site.
Detailed Summary
This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma.
Study Details
Timeline
Interventions
Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study: * Irinotecan 150 mg/m2 IV day 1 * Oxaliplatin 85 mg/m2 IV day 1 * Leucovorin 400 mg/m2 IV day 1 * 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus) * Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector) * Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7