- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02351219
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
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
PI
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Pisa, PI, Italy, 56126
- Azienda Ospedaliero-Universitaria Pisana
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FOLFOXIRI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radical resection rate
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: Within 24 months
|
Within 24 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Within 36 months
|
Within 36 months
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: within all the treatment period
|
within all the treatment period
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLAP study
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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