Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: FOLFOXIRI
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |