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

Pancreatic Cancer Clinical Trial

— GIP-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02355119
• Other study ID #: GIP-2
• Status: Recruiting
• Phase: Phase 3
• First received: January 20, 2015
• Last updated: February 3, 2015
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2015
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Enrico Vasile, MD, PhD
• Email: envasile[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• FOLFOXIRI
Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin
• Gemcitabine

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)		up to 1 year after last patient in	No
Secondary	Overall Survival (OS)		up to 2 years after last patient in	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		up to 28 weeks from treatment beginning	Yes