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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Krankenhaus Nordwest
• Treatments: Fluorouracil; Gemcitabine; Irinotecan; Oxaliplatin

Criteria

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