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drugset / Trial / NCT05066802

A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma

NCT05066802 ↗

Phase 2 Unknown 27 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

Within the next decade, pancreatic ductal adenocarcinoma (PDAC) is expected to rise to the second leading cause of cancer-related mortality. To increase the survival, various peri-operative treatments have been tested, and adjuvant FOLFIRINOX or gemcitabine plus capecitabine is now standard of care after surgical resection for localized PDAC. Even with superior survival among various disease extent of PDAC, resectable PDAC still shows poor outcomes with surgery followed by adjuvant chemotherapy. This phase II study is investigating the role of modified-FOLFIRINOX as neoadjuvant treatment for resectable PDAC.

Timeline

Start
2020-05-11
Primary completion
2022-05-31
Completion
2023-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 150 mg/m2 —
Subject Leucovorin Small molecule 400 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 2000 mg/m2 —

Indications

pancreatic adenocarcinoma