Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer (GIP-2)

Azienda Ospedaliero, Universitaria Pisana

Status and phase: Unknown; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: FOLFOXIRI; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02355119

GIP-2

Details and patient eligibility

About

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.

Full 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

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Gemcitabine

Active Comparator group

Description:

Gemcitabine 1000 mg/sqm on days 1,8,15 every 28 days

Treatment:

Drug: Gemcitabine

FOLFOXIRI

Experimental group

Treatment:

Drug: FOLFOXIRI