NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

Recruiting Phase 3 Interventional Study
Resectable Pancreatic Cancer Neoadjuvant Chemotherapy Effects of Chemotherapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
609 (estimated)
Sponsor
Seoul National University Hospital · Other
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About This Trial
Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: \- A. Age: 19 to 80 years old B. Patients with a score of 0 - 1 (ECOG) when selecting a study subject C. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological) D. Patients evaluated as resectable pancreatic cancer in preoperative …
Contacts

Jin-Young Jang

+82-2-2072-2194

jyjang4@snu.ac.kr

CONTACT

Myung-Ah Lee

angelamd@catholic.ac.kr

CONTACT