Clinical trial NCT02355119: Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: up to 1 year after last patient in
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 2 years after last patient in
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 28 weeks from treatment beginning
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Enrico Vasile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: