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Peri-operative S-1/Leucovorin, Oxaliplatin and Gemcitabine (SLOG) for Localized Pancreatic Cancer
1. To evaluate the efficacy of neoadjuvant chemotherapy SLOG in localized pancreatic cancer 2. To evaluate the safety profile in patients with pancreatic cancer who receive neoadjuvant SLOG 3. To collect tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation
The role of neoadjuvant treatment in pancreatic adenocarcinoma is still under debate due to a relative lack of robust data compared with other gastrointestinal cancers. According to 2020 NCCN guidelines, neoadjuvant is now the accepted approach for borderline resectable (BR) disease, while upfront surgery is still the recommendation for resectable disease except in cases with high risk features. Another important advantage of treatment with neoadjuvant treatment is an increase in the proportion of patients who receive chemotherapy. Traditionally, only patients with a good performance status and a good recovery after surgery are treated with adjuvant chemotherapy. About 45% of patients do not receive adjuvant chemotherapy after resection due to poor performance status, postoperative morbidity, or early progression of disease. A small cohort study using total neoadjuvant FOLFIRINOX for borderline resectable pancreatic cancer yielded a promising result but the tolerability of FOLFIRINOX limited the use of this regimen in Asian population. In previous T1211 clinical trial, the SLOG regimen showed comparable efficacy with a better safety profile in metastatic pancreatic cancer. This phase II trial will evaluate the feasibility of SLOG regimen in patients with localized pancreatic cancer.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan
National Institute of Cancer Research
Tainan, Taiwan
Start Date
September 3, 2021
Primary Completion Date
August 24, 2024
Completion Date
August 24, 2025
Last Updated
March 27, 2024
64
ESTIMATED participants
S-1, leucovorin, oxaliplatin and gemcitabine
DRUG
Lead Sponsor
National Health Research Institutes, Taiwan
NCT04657068
NCT06445062
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