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This refers to the control arm of the Phase 3 PRODIGE 98 (AMPIRINOX) clinical trial, which evaluates adjuvant treatment strategies for patients with resected ampullary adenocarcinoma. In this arm, patients receive monotherapy with either capecitabine or gemcitabine, selected at the investigator's discretion, rather than a combination of the two agents. Capecitabine is an oral fluoropyrimidine carbamate prodrug that is enzymatically converted to 5-fluorouracil, which inhibits thymidylate synthase and interferes with DNA synthesis. Gemcitabine is an intravenous nucleoside analog that inhibits DNA synthesis by blocking ribonucleotide reductase and competing with deoxycytidine triphosphate for incorporation into DNA. This regimen serves as the standard-of-care comparator against the experimental modified FOLFIRINOX (mFOLFIRINOX) regimen in the adjuvant setting following surgical resection.
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