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Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma

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ClinicalTrials.gov Identifier: NCT02172976
Recruitment Status : Recruiting
First Posted : June 24, 2014
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 6 cycles FOLFIRINOX followed by surgery followed by 6 cycles FOLFIRINOX.

The overall survival between both therapies will be compared as well as other parameters.

Condition or disease Intervention/treatment Phase
Resectable Prancreas Carcinoma Drug: Gemcitabine Drug: Oxaliplatin Drug: 5-Fluorouracil Drug: Irinotecan Drug: Natriumfolinate Phase 2 Phase 3

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 (6 cycles FOLFIRINOX neoadjuvant, 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
Study Start Date : November 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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
Drug: Oxaliplatin Drug: 5-Fluorouracil Drug: Irinotecan Drug: Natriumfolinate
Active Comparator: Gemcitabine
Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery
Drug: Gemcitabine

Outcome Measures

Primary Outcome Measures :
  1. median overall survival [ Time Frame: From date of randomization until the date of death from any cause assessed up to 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. perioperative morbidity and mortality [ Time Frame: 30 days after surgery ]
  3. R0 resection rate [ Time Frame: 2 months after surgery ]
  4. pathological complete remission [ Time Frame: at surgery ]
    during surgery, paraffin embedded tissue is prepared for analysis which is analyzed for remission grading at the central pathology afterwards

  5. adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm [ Time Frame: up to 40 weeks ]
  6. prevalence of iron deficiency [ Time Frame: baseline, d1 of every cycle, end of treatment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed ductal 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.
  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. Bilirubin < 1,6 mg/dl
  6. female and male patients > 18 years using contraception
  7. ECOG ≤ 1
  8. medical resectability
  9. granulocytes > 1.500/µl
  10. thrombocytes > 100.000/µl
  11. hemoglobin ≥ 8,0 g/dl
  12. serumcreatinine ≤ 1.5x of normal value or Creatinine-Clearance > 50 ml/min
  13. written informed consent

Exclusion Criteria:

  1. Endocrine and acinar pancreas carcinoma
  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, Bilirubin>1,5xULN)
  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
Contacts and Locations

Information from the National Library of Medicine

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): NCT02172976

Contact: Salah-Eddin Al-Batran, Prof. +496976014420 albatran@khnw.de
Contact: Claudia Pauligk, PhD +496976013906 pauligk.claudia@khnw.de

Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany Recruiting
Frankfurt, Germany, 60488
Contact: Alexander Reichart, MD    +496976014350      
Contact: Claudia Pauligk    +496976013906    pauligk.claudia@khnw.de   
Sponsors and Collaborators
Krankenhaus Nordwest
Principal Investigator: Alexander Reichart, Dr. Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
More Information

Additional Information:
Responsible Party: Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT02172976     History of Changes
Other Study ID Numbers: NEPAFOX
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by Krankenhaus Nordwest:
pancreas cancer
neoadjuvant chemotherapy

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors