Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
GIP-2
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
1 other identifier
interventional
310
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pancreatic-cancer
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 4, 2015
January 1, 2015
2.9 years
January 20, 2015
February 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival (DFS)
up to 1 year after last patient in
Secondary Outcomes (2)
Overall Survival (OS)
up to 2 years after last patient in
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
up to 28 weeks from treatment beginning
Study Arms (2)
Gemcitabine
ACTIVE COMPARATORGemcitabine 1000 mg/sqm on days 1,8,15 every 28 days
FOLFOXIRI
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enrico Vasile, MD, PhD
Azienda Ospedaliero, Universitaria Pisana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 20, 2015
First Posted
February 4, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
February 4, 2015
Record last verified: 2015-01