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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
Sponsor:
Information provided by (Responsible Party):
Enrico Vasile, 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.


Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Stage III Drug: FOLFOXIRI Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FOLFOXIRI Drug: FOLFOXIRI



Primary Outcome Measures :
  1. Radical resection rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Within 24 months ]

Other Outcome Measures:
  1. Overall survival [ Time Frame: Within 36 months ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: within all the treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy, 56126
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana

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Responsible Party: Enrico Vasile, MD, PhD, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT02351219     History of Changes
Other Study ID Numbers: FLAP study
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases