Back to resultsNeoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
Primary Purpose
Borderline Resectable Pancreatic Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
FOLFIRINOX
gemcitabine + nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Resectable Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
- first treatment for pancreatic cancer
- performance status 0 or 1
- adequate one marrow function
- adequate renal function
- obtained informed consent
Exclusion Criteria:
- other active concomitant malignancies
- other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
- pregnant women
- no informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FOLFIRINOX
GEM + nab-PTX
Arm Description
4 course of FILFIRINOX before surgery
2 course of GEM + nab-PTX before surgery
Outcomes
Primary Outcome Measures
R0 resection rate
surgery is supposed to be performed 3 months after the initiation of chemotherapy
Secondary Outcome Measures
completion rate of chemotherapy
chemotherapy is supposed to take 3 months
relative dose intensity
chemotherapy is supposed to take 3 months
adverse event
chemotherapy is supposed to take 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
disease free survival
overall survival
surgical complication
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02717091
Brief Title
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
Official Title
Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya University
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Resectable Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRINOX
Arm Type
Experimental
Arm Description
4 course of FILFIRINOX before surgery
Arm Title
GEM + nab-PTX
Arm Type
Experimental
Arm Description
2 course of GEM + nab-PTX before surgery
Intervention Type
Drug
Intervention Name(s)
FOLFIRINOX
Intervention Type
Drug
Intervention Name(s)
gemcitabine + nab-paclitaxel
Primary Outcome Measure Information:
Title
R0 resection rate
Description
surgery is supposed to be performed 3 months after the initiation of chemotherapy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
completion rate of chemotherapy
Description
chemotherapy is supposed to take 3 months
Time Frame
3 months
Title
relative dose intensity
Description
chemotherapy is supposed to take 3 months
Time Frame
3 months
Title
adverse event
Description
chemotherapy is supposed to take 3 months
Time Frame
3 months
Title
tumor response
Description
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
Time Frame
3 months
Title
disease free survival
Time Frame
3 years after the surgery
Title
overall survival
Time Frame
3 years after the surgery
Title
surgical complication
Time Frame
1 month after the surgery
Title
quality of the tumor
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
first treatment for pancreatic cancer
performance status 0 or 1
adequate one marrow function
adequate renal function
obtained informed consent
Exclusion Criteria:
other active concomitant malignancies
other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
pregnant women
no informed consent
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
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