A Phase 2 interventional study of FOLFOXIRI in Pancreatic Carcinoma Stage III, sponsored by Azienda Ospedaliero, Universitaria Pisana. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-01-30.
Sponsored by Azienda Ospedaliero, Universitaria Pisana · Phase 2, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 50 is close to the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 56 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Stage III unresectable pancreatic cancer defined for:
Exclusion Criteria:
Drug: FOLFOXIRI
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
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero, Universitaria Pisana