2015-07
2020-06
2023-06
50
NCT02717091
Nagoya University
Nagoya University
INTERVENTIONAL
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.
N/A
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 |
|---|---|---|
2016-02-11 | N/A | 2020-09-08 |
2016-03-22 | N/A | 2020-09-10 |
2016-03-23 | N/A | 2020-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: FOLFIRINOX 4 course of FILFIRINOX before surgery | DRUG: FOLFIRINOX |
| EXPERIMENTAL: GEM + nab-PTX 2 course of GEM + nab-PTX before surgery | DRUG: gemcitabine + nab-paclitaxel |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| R0 resection rate | surgery is supposed to be performed 3 months after the initiation of chemotherapy | 3 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| completion rate of chemotherapy | chemotherapy is supposed to take 3 months | 3 months |
| relative dose intensity | chemotherapy is supposed to take 3 months | 3 months |
| adverse event | chemotherapy is supposed to take 3 months | 3 months |
| tumor response | tumor response to chemotherapy will be assessed based on Response Evaluation Criteria In Solid Tumor (RECIST). CR: Complete Response, PR: Partial Response, PD: Progression, SD: Stable Disease, NE: Not Evaluable | 3 months |
| disease free survival | 3 years after the surgery | |
| overall survival | 3 years after the surgery | |
| surgical complication | 1 month after the surgery | |
| quality of the tumor | Chemotherapy is supposed to take 3 months. After the completion of chemotherapy, the quality of the tumor will be assessed by imaging findings, such as CT number and Standardized uptake value. | 3 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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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