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

Conditions

Resectable Prancreas Carcinoma

Keywords

pancreas cancer, neoadjuvant chemotherapy, Folfirinox, gemcitabine

Brief 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.

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.

Salah‐Eddin Al‐Batran, Alexander Reichart, Ulli Simone Bankstahl, Claudia Pauligk, Thomas Kraus et al. (19 authors)

Journal of Clinical Oncology2021-01-2036 citations

10.1200/jco.2021.39.3_suppl.406

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BMC Cancer2018-12-0175 citations

10.1186/s12885-018-5183-y

Randomized multicenter phase II/III study with adjuvant gemcitabine versus neoadjuvant/adjuvant FOLFIRINOX in resectable pancreatic cancer: The NEPAFOX trial.

Wael Hozaeel, Claudia Pauligk, Nils Homann, Kim Barbara Luley, Thomas Kraus et al. (12 authors)

Journal of Clinical Oncology2015-05-2019 citations

10.1200/jco.2015.33.15_suppl.tps4152

Interventions

DRUGGemcitabine

DRUGOxaliplatin

DRUG5-Fluorouracil

DRUGIrinotecan

DRUGNatriumfolinate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
perioperative morbidity and mortality	30 days after surgery	—
R0 resection rate	2 months after surgery	—
median progression-free survival (PFS)	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	—
adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm	up to 40 weeks	—
prevalence of iron deficiency	baseline, d1 of every cycle, end of treatment	—
pathological complete remission	at surgery	during surgery, paraffin embedded tissue is prepared for analysis which is analyzed for remission grading at the central pathology afterwards

Countries

Germany

Outcome results

None listed