Pancreatic Carcinoma Stage III Clinical Trial
— FLAPOfficial title:
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | PI |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Ospedaliero, Universitaria Pisana |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Overall survival | Within 36 months | No | |
| Other | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | within all the treatment period | Yes | |
| Primary | Radical resection rate | 6 months | No | |
| Secondary | Progression-free survival | Within 24 months | No |