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Completed

NCT Number: NCT02351219

FOLFOXIRI as Primary Treatment for 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.

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Key information

Conditions

Pancreatic Carcinoma Stage III Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLFOXIRI

Drug

Primary outcomes

  1. Radical resection rate

    Time frame: 6 months

Secondary outcomes

  1. Progression-free survival

    Time frame: Within 24 months

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer

Acronym: FLAP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2015
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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