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

Krankenhaus Nordwest

Status and phase: Completed; Phase 3; Phase 2

Conditions: Resectable Prancreas Carcinoma

Treatments: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Natriumfolinate; Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT02172976

NEPAFOX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

FOLFIRINOX

Experimental group

Description:

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

Treatment:

Drug: Natriumfolinate

Drug: Irinotecan

Drug: Oxaliplatin

Drug: 5-Fluorouracil

Gemcitabine

Active Comparator group

Description:

Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery

Treatment:

Drug: Gemcitabine