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NCT Number: NCT02172976

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

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.

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Key information

Conditions

Resectable Prancreas Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Frankfurt, 60488, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Gemcitabine

Drug

Oxaliplatin

Drug

5-fluorouracil

Drug

Irinotecan

Drug

Natriumfolinate

Drug

Primary outcomes

  1. median overall survival

    Time frame: From date of randomization until the date of death from any cause assessed up to 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Krankenhaus Nordwest

Other

Registry information

Official study title

Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2014
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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