Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer (GIP-2)

February 3, 2015 updated by: Enrico Vasile, Azienda Ospedaliero, Universitaria Pisana

Phase III Italian Multicenter Study Comparing the Combination of 5-fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan (Folfoxiri) Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer

Patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm.

A total of 310 patients will be enrolled in about 50 Italian centers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with resected stage I-III pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm.

A total of 310 patients will be enrolled in about 50 Italian centers. All the patients will be followed up during and after the treatment until disease progression and death or for a minimum of 60 months.

Main objective:

To show an increase in disease-free survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm.

Secondary objectives:

To show an increase in overall survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm.

To show the tolerability of the experimental treatment in this setting.

Principal inclusion criteria:

  • histological diagnosis of pancreatic cancer
  • surgical resection with curative intent within 10 weeks before of enrollment (stage I-III)
  • absence of evidence of metastases (cM0)
  • age 18-75
  • ECOG performance status 0-1
  • adequate bone marrow, liver and renal function
  • written informed consent

Principal exclusion criteria:

  • evidence of metastases
  • CA19.9 higher than 2.5 x ULN (upper limit of normal range)
  • precedent chemotherapy or radiotherapy
  • coexisting malignancies
  • relevant coexisting diseases that could contraindicate the participation to the study
  • hypersensitivity/intolerance to the drugs in study
  • pregnancy or breastfeeding
  • neurotoxicity of grade > 1
  • malabsorption syndrome

Primary end-point:

Disease-free survival, defined as the time from enrollment to the evidence of progression of disease or death.

Secondary end-points:

Overall survival, defined as the time from enrollment to the evidence of death. Toxicity, defined according to NCI-CTC

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero-Universitaria Pisana
        • Contact:
          • Enrico Vasile, MD, PhD
          • Phone Number: +39 050 992466
          • Email: envasile@tin.it
        • Principal Investigator:
          • Enrico Vasile, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histological diagnosis of pancreatic cancer
  • surgical resection with curative intent within 10 weeks before of enrollment (stage I-III)
  • absence of evidence of metastases (cM0)
  • age 18-75
  • ECOG performance status 0-1
  • adequate bone marrow, liver and renal function
  • written informed consent

Exclusion Criteria:

  • evidence of metastases
  • CA19.9 higher than 2.5 x ULN (upper limit of normal range)
  • precedent chemotherapy or radiotherapy
  • coexisting malignancies
  • relevant coexisting diseases that could contraindicate the participation to the study
  • hypersensitivity/intolerance to the drugs in study
  • pregnancy or breastfeeding
  • neurotoxicity of grade > 1
  • malabsorption syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gemcitabine
Gemcitabine 1000 mg/sqm on days 1,8,15 every 28 days
Drug: Gemcitabine
Experimental: FOLFOXIRI
Drug: FOLFOXIRI
Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival (DFS)
Time Frame: up to 1 year after last patient in
up to 1 year after last patient in

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: up to 2 years after last patient in
up to 2 years after last patient in
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 28 weeks from treatment beginning
up to 28 weeks from treatment beginning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Investigators

  • Principal Investigator: Enrico Vasile, MD, PhD, Azienda Ospedaliero, Universitaria Pisana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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