- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02717091
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
September 8, 2020 updated by: Junpei Yamaguchi, Nagoya University
Phase II Study of 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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Participation Criteria
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.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FOLFIRINOX
4 course of FILFIRINOX before surgery
|
|
Experimental: GEM + nab-PTX
2 course of GEM + nab-PTX before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection rate
Time Frame: 3 months
|
surgery is supposed to be performed 3 months after the initiation of chemotherapy
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
completion rate of chemotherapy
Time Frame: 3 months
|
chemotherapy is supposed to take 3 months
|
3 months
|
relative dose intensity
Time Frame: 3 months
|
chemotherapy is supposed to take 3 months
|
3 months
|
adverse event
Time Frame: 3 months
|
chemotherapy is supposed to take 3 months
|
3 months
|
tumor response
Time Frame: 3 months
|
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
Time Frame: 3 years after the surgery
|
3 years after the surgery
|
|
overall survival
Time Frame: 3 years after the surgery
|
3 years after the surgery
|
|
surgical complication
Time Frame: 1 month after the surgery
|
1 month after the surgery
|
|
quality of the tumor
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
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 Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
June 1, 2020
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
March 22, 2016
First Posted (Estimate)
March 23, 2016
Study Record Updates
Last Update Posted (Actual)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 8, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
- Folfirinox
Other Study ID Numbers
- NUDC1508
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on FOLFIRINOX
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The University of Texas Health Science Center,...WithdrawnPancreatic Adenocarcinoma