Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer (GIP-2)
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|ClinicalTrials.gov Identifier: NCT02355119|
Recruitment Status : Unknown
Verified January 2015 by Enrico Vasile, Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was: Recruiting
First Posted : February 4, 2015
Last Update Posted : February 4, 2015
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|
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.
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.
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
Disease-free survival, defined as the time from enrollment to the evidence of progression of disease or death.
Overall survival, defined as the time from enrollment to the evidence of death. Toxicity, defined according to NCI-CTC
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||January 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Gemcitabine
Gemcitabine 1000 mg/sqm on days 1,8,15 every 28 days
Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin
- Disease free survival (DFS) [ Time Frame: up to 1 year after last patient in ]
- Overall Survival (OS) [ Time Frame: up to 2 years after last patient in ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 28 weeks from treatment beginning ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355119
|Contact: Enrico Vasile, MD, PhDfirstname.lastname@example.org|
|Azienda Ospedaliero-Universitaria Pisana||Recruiting|
|Pisa, PI, Italy, 56126|
|Contact: Enrico Vasile, MD, PhD +39 050 992466 email@example.com|
|Principal Investigator: Enrico Vasile, MD, PhD|
|Principal Investigator:||Enrico Vasile, MD, PhD||Azienda Ospedaliero, Universitaria Pisana|