FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer (FLAP)
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|ClinicalTrials.gov Identifier: NCT02351219|
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : January 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Carcinoma Stage III||Drug: FOLFOXIRI||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
- Radical resection rate [ Time Frame: 6 months ]
- Progression-free survival [ Time Frame: Within 24 months ]
- Overall survival [ Time Frame: Within 36 months ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: within all the treatment period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351219
|Azienda Ospedaliero-Universitaria Pisana|
|Pisa, PI, Italy, 56126|