2017-11-01
2021-12-31
2021-12-31
35
NCT03316326
National Taiwan University Hospital
National Taiwan University Hospital
INTERVENTIONAL
S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection.
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. The primary endpoint of this study is resection rate after neoadjuvant chemotherapy. The first stage will enroll 18 patients. We will go into the second stage if at least 2 patients in stage I become resectable after treatment. There will be at most 35 patients enrolled. Based on this trial, we anticipate that the SIROX regimen has comparable response rate and resection rate but lower toxicities comparing to FOLFIRINOX.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-10-16 | N/A | 2017-10-19 |
2017-10-19 | N/A | 2017-10-20 |
2017-10-20 | N/A | 2017-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: SIROX Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination | DRUG: Tegafur-gimeracil-oteracil potassium
DRUG: Oxaliplatin
DRUG: Irinotecan
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| resection rate | patients with R0 or R1 resection of the primary tumor after study chemotherapy/patients receiving at least one dose of study chemotherapy | 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| response rate (RR) | RR of SIROX | 3 years |
| Overall survival (OS) | OS of all patients | 4 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Shih-Hung Yang, M.D. Phone Number: +886-2-23123456 Email: 018500@ntuh.gov.tw |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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