Resectable Prancreas CarcinomaPhase 2/3NCT02172976
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
A Phase 2/3 study testing Gemcitabine, Oxaliplatin and 5-Fluorouracil in people with Resectable Prancreas Carcinoma, run by Krankenhaus Nordwest at 1 site in Germany.
Trial summary
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX. The overall survival between both therapies will be compared as well as other parameters. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Prancreas Carcinoma
- What is being tested?
- Gemcitabine, Oxaliplatin and 5-Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to May 2020
- Phase
- Phase 2/3
- 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
- Histologically confirmed adenocarcinoma of the pankreas. For histological confirmation, max. 3 tests are allowed. If no confirmation of carcinoma is possible, the patient can not be included into the study.
- Radiological confirmation of a locally limited curativ resectable (primarily resectale or borderline situation) pankreas carcinoma without distant metastases.
- no prior pancreas resection
- no prior cytostatic chemotherapy
- female and male patients > 18 and <=75 years using contraception
- ECOG ≤ 1
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- medical resectability
- granulocytes > 1.500/µl
- thrombocytes > 100.000/µl
- hemoglobin ≥ 8,0 g/dl
- serumcreatinine ≤ 1.5x of normal value or Creatinine-Clearance > 50 ml/min
- written informed consent
Who cannot join
- Endocrine pancreas carcinoma
- locally advanced inoperable stages: non-resectable infiltration of V. porta or longway infiltration of A. mesenterica superior or infiltration of Truncus coeliacus.
- distant metastases
- Relapse
- prior radiotherapy of measurable lesions
- peritonealcarcinosis
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- malignant secondary disease, dated back < 5 years (exeption: in-situ-carcinoma of the cervix, adequately treated skin basal cell carcinoma)
- contraindication for operative resection
- ECOG ≥ 2
- severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN)
- Transhepatic drainage
- active CHD (symptoms present), cardiomyopathy or heart insufficiency stage III-IV according to NYHA and EF < 45%
- severe non-surgical accompanying diseases or acute infection
- chronic diarrhea
- chronic inflammable gastro-intestinal disease
- peripheral polyneuropathy > NCI grade II
- pregnancy or lactation
- hypersensibility or contraindication for Gemcitabine, Oxaliplatin, Natriumfolinate, Irinotecan or 5-Fluorouracil
- participation in another interventional trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Frankfurt, 60488
About this study
Official title: Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX.
The overall survival between both therapies will be compared as well as other parameters.
Read the detailed description
This is a phase II/III randomized multicenter study. Patients with resectable pancreatic carcinoma will be randomized in Arm A (surgery plus adjuvant gemcitabine, 6 cycles) or Arm B (4-6 cycles FOLFIRINOX neoadjuvant, 4-6 cycles FOLFIRINOX adjuvant).
Primary endpoint is the overall survival, secondary endpoints are progression-free survival, perioperative morbidity and mortality, rate of R0 resections, tolerability and feasibility of neoadjuvant FOLFIRINOX and others.
- Conditions
- Resectable Prancreas Carcinoma
- Being tested
- Gemcitabine, Oxaliplatin, 5-Fluorouracil, Irinotecan, Natriumfolinate
- Keywords
- pancreas cancer, neoadjuvant chemotherapy, Folfirinox, 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.
GemcitabineDrug
OxaliplatinDrug
5-FluorouracilDrug
IrinotecanDrug
NatriumfolinateDrug
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | Oxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery Receives: Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Irinotecan; Drug: Natriumfolinate |
| Gemcitabine | Active comparator | Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
median overall survival
Measured: From date of randomization until the date of death from any cause assessed up to 24 months
Secondary outcomes (6)
median progression-free survival (PFS)
Measured: From date of randomization until the date of first documented progression / relapse or date of death from any cause, whichever came first, assessed up to 24 months
perioperative morbidity and mortality
Measured: 30 days after surgery
R0 resection rate
Measured: 2 months after surgery
pathological complete remission
during surgery, paraffin embedded tissue is prepared for analysis which is analyzed for remission grading at the central pathology afterwards
Measured: at surgery
adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm
Measured: up to 40 weeks
prevalence of iron deficiency
Measured: baseline, d1 of every cycle, end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Prancreas CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof., Principal investigator, Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172976
- Sponsor's protocol ID
- NEPAFOX
- Status last verified
- Sep 2020
- First submitted
- 23 May 2014
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02172976
- Acronym / sponsor ID
- NEPAFOX
- Conditions
- Resectable Prancreas Carcinoma
- Keywords
- pancreas cancer, neoadjuvant chemotherapy, Folfirinox, gemcitabine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Krankenhaus NordwestUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 24 Jun 2014 (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.
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX.
The overall survival between both therapies will be compared as well as other parameters.
Detailed description
This is a phase II/III randomized multicenter study. Patients with resectable pancreatic carcinoma will be randomized in Arm A (surgery plus adjuvant gemcitabine, 6 cycles) or Arm B (4-6 cycles FOLFIRINOX neoadjuvant, 4-6 cycles FOLFIRINOX adjuvant).
Primary endpoint is the overall survival, secondary endpoints are progression-free survival, perioperative morbidity and mortality, rate of R0 resections, tolerability and feasibility of neoadjuvant FOLFIRINOX and others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Experimental | Drug: Oxaliplatin, Drug: 5-Fluorouracil, Drug: Irinotecan, Drug: NatriumfolinateOxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery |
| Gemcitabine | Active comparator | Drug: GemcitabineGemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed adenocarcinoma of the pankreas. For histological confirmation, max. 3 tests are allowed. If no confirmation of carcinoma is possible, the patient can not be included into the study.
- Radiological confirmation of a locally limited curativ resectable (primarily resectale or borderline situation) pankreas carcinoma without distant metastases.
- no prior pancreas resection
- no prior cytostatic chemotherapy
- female and male patients > 18 and <=75 years using contraception
Key exclusion criteria (19 listed)
- Endocrine pancreas carcinoma
- locally advanced inoperable stages: non-resectable infiltration of V. porta or longway infiltration of A. mesenterica superior or infiltration of Truncus coeliacus.
- distant metastases
- Relapse
- prior radiotherapy of measurable lesions
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 |
|---|---|---|
| Gemcitabine | Drug | Gemcitabine |
| Oxaliplatin | Drug | FOLFIRINOX |
| 5-Fluorouracil | Drug | FOLFIRINOX |
| Irinotecan | Drug | FOLFIRINOX |
| Natriumfolinate | Drug | FOLFIRINOX |
Primary outcome
median overall survival
Time frame: From date of randomization until the date of death from any cause assessed up to 24 months
6 secondary outcomes
median progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression / relapse or date of death from any cause, whichever came first, assessed up to 24 months
perioperative morbidity and mortality
Time frame: 30 days after surgery
R0 resection rate
Time frame: 2 months after surgery
pathological complete remission
Time frame: at surgery
adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm
Time frame: up to 40 weeks
prevalence of iron deficiency
Time frame: baseline, d1 of every cycle, end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No IPD will be shared
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.
Salah-Eddin Al-Batran, Prof. principal investigator
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gemcitabine, Oxaliplatin and 5-Fluorouracil in people with Resectable Prancreas Carcinoma, run by Krankenhaus Nordwest at 1 site in Germany.
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 12 inclusion and 19 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median overall survival (time frame: From date of randomization until the date of death from any cause assessed up to 24 months). 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 2 Sep 2020; AzTrials last refreshed its copy on 28 Oct 2026.