FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer
FLAP
Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedJanuary 30, 2015
January 1, 2015
2 years
January 20, 2015
January 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Radical resection rate
6 months
Secondary Outcomes (1)
Progression-free survival
Within 24 months
Other Outcomes (2)
Overall survival
Within 36 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
within all the treatment period
Study Arms (1)
FOLFOXIRI
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of distant metastases
- Cardiovascular diseases
- Contraindications to studied drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 30, 2015
Study Start
December 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 30, 2015
Record last verified: 2015-01