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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOXIRI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOXIRI | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radical resection rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Within 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Within 36 months | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | within all the treatment period |
Inclusion Criteria:
Stage III unresectable pancreatic cancer defined for:
ECOG Performance Status 0-1
Age 18-75
Adequate liver, renal and bone marrow function
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Pisana | Pisa | PI | 56126 | Italy |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C509829 | FOLFOXIRI protocol |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |