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Trial record 1 of 1 for:    NCT02355119
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Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer (GIP-2)

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ClinicalTrials.gov Identifier: NCT02355119
Recruitment Status : Unknown
Verified January 2015 by Enrico Vasile, Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
First Posted : February 4, 2015
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Enrico Vasile, Azienda Ospedaliero, Universitaria Pisana

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: FOLFOXIRI Drug: Gemcitabine Phase 3

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  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: up to 1 year after last patient in ]

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


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:

  • 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

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): NCT02355119


Contacts
Contact: Enrico Vasile, MD, PhD envasile@tin.it

Locations
Italy
Azienda Ospedaliero-Universitaria Pisana Recruiting
Pisa, PI, Italy, 56126
Contact: Enrico Vasile, MD, PhD    +39 050 992466    envasile@tin.it   
Principal Investigator: Enrico Vasile, MD, PhD         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Investigators
Principal Investigator: Enrico Vasile, MD, PhD Azienda Ospedaliero, Universitaria Pisana

Responsible Party: Enrico Vasile, PI, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT02355119     History of Changes
Other Study ID Numbers: GIP-2
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs