Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
NCT ID: NCT02172976
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2014-11-30
2020-05-31
Brief Summary
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The overall survival between both therapies will be compared as well as other parameters.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FOLFIRINOX
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
Oxaliplatin
5-Fluorouracil
Irinotecan
Natriumfolinate
Gemcitabine
Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery
Gemcitabine
Interventions
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Gemcitabine
Oxaliplatin
5-Fluorouracil
Irinotecan
Natriumfolinate
Eligibility Criteria
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Inclusion Criteria
2. Radiological confirmation of a locally limited curativ resectable (primarily resectale or borderline situation) pankreas carcinoma without distant metastases.
3. no prior pancreas resection
4. no prior cytostatic chemotherapy
5. female and male patients \> 18 and \<=75 years using contraception
6. ECOG ≤ 1
7. medical resectability
8. granulocytes \> 1.500/µl
9. thrombocytes \> 100.000/µl
10. hemoglobin ≥ 8,0 g/dl
11. serumcreatinine ≤ 1.5x of normal value or Creatinine-Clearance \> 50 ml/min
12. written informed consent
Exclusion Criteria
2. locally advanced inoperable stages: non-resectable infiltration of V. porta or longway infiltration of A. mesenterica superior or infiltration of Truncus coeliacus.
3. distant metastases
4. Relapse
5. prior radiotherapy of measurable lesions
6. peritonealcarcinosis
7. malignant secondary disease, dated back \< 5 years (exeption: in-situ-carcinoma of the cervix, adequately treated skin basal cell carcinoma)
8. contraindication for operative resection
9. ECOG ≥ 2
10. severe liver dysfunction (AST/ALT\>3,5xULN, AP\>6xULN)
11. Transhepatic drainage
12. active CHD (symptoms present), cardiomyopathy or heart insufficiency stage III-IV according to NYHA and EF \< 45%
13. severe non-surgical accompanying diseases or acute infection
14. chronic diarrhea
15. chronic inflammable gastro-intestinal disease
16. peripheral polyneuropathy \> NCI grade II
17. pregnancy or lactation
18. hypersensibility or contraindication for Gemcitabine, Oxaliplatin, Natriumfolinate, Irinotecan or 5-Fluorouracil
19. participation in another interventional trial
18 Years
75 Years
ALL
No
Sponsors
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Krankenhaus Nordwest
OTHER
Responsible Party
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Principal Investigators
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Salah-Eddin Al-Batran, Prof.
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Locations
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Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Frankfurt, , Germany
Countries
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Related Links
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Related Info
Other Identifiers
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NEPAFOX
Identifier Type: -
Identifier Source: org_study_id
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