Resectable Prancreas Carcinoma Clinical Trial
Official title:
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
| Verified date | September 2020 |
| Source | Krankenhaus Nordwest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | May 2020 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany | Frankfurt |
| Lead Sponsor | Collaborator |
|---|---|
| Krankenhaus Nordwest |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | median overall survival | From date of randomization until the date of death from any cause assessed up to 24 months | ||
| Secondary | 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 | ||
| Secondary | perioperative morbidity and mortality | 30 days after surgery | ||
| Secondary | R0 resection rate | 2 months after surgery | ||
| Secondary | pathological complete remission | during surgery, paraffin embedded tissue is prepared for analysis which is analyzed for remission grading at the central pathology afterwards | at surgery | |
| Secondary | adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm | up to 40 weeks | ||
| Secondary | prevalence of iron deficiency | baseline, d1 of every cycle, end of treatment |