Pancreatic CancerPhase 3GIP-2NCT02355119
Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
A Phase 3 study testing FOLFOXIRI and Gemcitabine in people with Pancreatic Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- FOLFOXIRI and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- pregnancy or breastfeeding
- neurotoxicity of grade > 1
- malabsorption syndrome
Trial locations and contacts
1 site in 1 country.
Enrico Vasile, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56126
Enrico Vasile, MD, PhD, +39 050 992466, envasile@tin.it
Enrico Vasile, MD, PhD
About this study
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
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.
Read the 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
- Conditions
- Pancreatic Cancer
- Being tested
- FOLFOXIRI, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | Gemcitabine 1000 mg/sqm on days 1,8,15 every 28 days Receives: Drug: Gemcitabine |
| FOLFOXIRI | Experimental | Not described Receives: Drug: FOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Measured: up to 1 year after last patient in
Secondary outcomes (2)
Overall Survival (OS)
Measured: up to 2 years after last patient in
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up to 28 weeks from treatment beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Vasile, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Enrico Vasile, MD, PhD, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355119
- Sponsor's protocol ID
- GIP-2
- Acronym
- GIP-2
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2015
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02355119
- Acronym / sponsor ID
- GIP-2 / GIP-2
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Active comparator | Drug: GemcitabineGemcitabine 1000 mg/sqm on days 1,8,15 every 28 days |
| FOLFOXIRI | Experimental | Drug: FOLFOXIRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOXIRICombination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin | Drug | FOLFOXIRI |
| Gemcitabine | Drug | Gemcitabine |
Primary outcome
Disease free survival (DFS)
Time frame: up to 1 year after last patient in
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico Vasile, MD, PhD contact
Enrico Vasile, MD, PhD principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFOXIRI and Gemcitabine in people with Pancreatic Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico Vasile, MD, PhD (envasile@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: up to 1 year after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.