FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Carcinoma Stage III
• Interventions: Drug: FOLFOXIRI

• Registration Number: NCT02351219
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Study First Posted: 2015-01-30
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFOXIRI	FOLFOXIRI	-

Primary Outcome Measures

Name	Time	Method
Radical resection rate	6 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Within 24 months

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy