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

September 1, 2020 updated by: Krankenhaus Nordwest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60488
        • Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  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:

  1. Endocrine 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)
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
median overall survival
Time Frame: From date of randomization until the date of death from any cause assessed up to 24 months
From date of randomization until the date of death from any cause assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
30 days after surgery
R0 resection rate
Time Frame: 2 months after surgery
2 months after surgery
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
at surgery
adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm
Time Frame: up to 40 weeks
up to 40 weeks
prevalence of iron deficiency
Time Frame: baseline, d1 of every cycle, end of treatment
baseline, d1 of every cycle, end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Nordwest

Investigators

  • Principal Investigator: Salah-Eddin Al-Batran, Prof., Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEPAFOX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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