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

Sponsor

Azienda Ospedaliero, Universitaria Pisana (Other)

Overall Status

Unknown status

CT.gov ID

NCT02355119

Collaborator

(none)

310

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: FOLFOXIRI Drug: Gemcitabine	Phase 3

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

310 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Gemcitabine

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

Drug: Gemcitabine

Experimental: FOLFOXIRI

Drug: FOLFOXIRI

Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin

Outcome Measures

Primary Outcome Measures

Disease free survival (DFS) [up to 1 year after last patient in]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI	Italy	56126

Sponsors and Collaborators

Azienda Ospedaliero, Universitaria Pisana

Investigators

Principal Investigator: Enrico Vasile, MD, PhD, Azienda Ospedaliero, Universitaria Pisana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Enrico Vasile, PI, Azienda Ospedaliero, Universitaria Pisana

ClinicalTrials.gov Identifier:

NCT02355119

Other Study ID Numbers:

GIP-2

First Posted:

Feb 4, 2015

Last Update Posted:

Feb 4, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Pancreatic Neoplasms

Gemcitabine

Study Results

No Results Posted as of Feb 4, 2015