Peri-operative SLOG for Localized Pancreatic Cancer
NCT05048524 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2024-03-27
Summary
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
Conditions
- Pancreatic Ductal Adenocarcinoma
- Pancreas Cancer
Interventions
- DRUG
-
S-1, leucovorin, oxaliplatin and gemcitabine
Gemcitabine 800 mg/m2 on day 1, oxaliplatin 85 mg/m2 on day 1, S-1 orally 80-120 mg/day \[depending on patient's body surface area (BSA)\] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows: * BSA \< 1.25 m2: 80 mg/day * 1.25 m2 ≤ BSA \< 1.5 m2: 100 mg/day * BSA ≥ 1.5 m2: 120 mg/day
Sponsors & Collaborators
-
National Health Research Institutes, Taiwan
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-03
- Primary Completion
- 2024-08-24
- Completion
- 2025-08-24
Countries
- Taiwan
Study Locations
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