FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer (FLAP)
Primary Purpose
Pancreatic Carcinoma Stage III
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
FOLFOXIRI
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Carcinoma Stage III
Eligibility Criteria
Inclusion Criteria:
Stage III unresectable pancreatic cancer defined for:
- extended encasement of superior mesenteric artery or celiac axis/hepatic artery
- both arterial and venous (portal vein/superior mesenteric vein) encasement
- unreconstructible vessel encasement
- ECOG Performance Status 0-1
- Age 18-75
- Adequate liver, renal and bone marrow function
Exclusion Criteria:
- Evidence of distant metastases
- Cardiovascular diseases
- Contraindications to studied drugs
Sites / Locations
- Azienda Ospedaliero-Universitaria Pisana
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFOXIRI
Arm Description
Outcomes
Primary Outcome Measures
Radical resection rate
Secondary Outcome Measures
Progression-free survival
Full Information
NCT ID
NCT02351219
First Posted
January 20, 2015
Last Updated
January 27, 2015
Sponsor
Azienda Ospedaliero, Universitaria Pisana
1. Study Identification
Unique Protocol Identification Number
NCT02351219
Brief Title
FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer
Acronym
FLAP
Official Title
Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible.
After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.
In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy.
Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy.
Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma Stage III
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFOXIRI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FOLFOXIRI
Primary Outcome Measure Information:
Title
Radical resection rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Within 24 months
Other Pre-specified Outcome Measures:
Title
Overall survival
Time Frame
Within 36 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
within all the treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III unresectable pancreatic cancer defined for:
extended encasement of superior mesenteric artery or celiac axis/hepatic artery
both arterial and venous (portal vein/superior mesenteric vein) encasement
unreconstructible vessel encasement
ECOG Performance Status 0-1
Age 18-75
Adequate liver, renal and bone marrow function
Exclusion Criteria:
Evidence of distant metastases
Cardiovascular diseases
Contraindications to studied drugs
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer
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