Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
NCT ID: NCT02355119
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
310 participants
INTERVENTIONAL
2015-01-31
2018-12-31
Brief Summary
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A total of 310 patients will be enrolled in about 50 Italian centers.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine
Gemcitabine 1000 mg/sqm on days 1,8,15 every 28 days
Gemcitabine
FOLFOXIRI
FOLFOXIRI
Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin
Interventions
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FOLFOXIRI
Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin
Gemcitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Azienda Ospedaliero, Universitaria Pisana
OTHER
Responsible Party
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Enrico Vasile
PI
Principal Investigators
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Enrico Vasile, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero, Universitaria Pisana
Locations
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Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GIP-2
Identifier Type: -
Identifier Source: org_study_id
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