A study with gemcitabine or FOLFIRINOX for patients with operable pancreatic cancer
- Conditions
- resectable adenocarcinoma of the pancreasMedDRA version: 20.0Level: LLTClassification code 10033578Term: Pancreas carcinoma resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10052747Term: Adenocarcinoma pancreasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003972-11-DE
- Lead Sponsor
- Institut für Klinisch-Onkologische Forschung Krankenhaus Nordwest GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
1.Histologically confirmed adenocarcinoma of the pancreas
2.Radiological confirmation of a local curative resectable (primarily resectable or borderline situation) pancreas carcinoma without distant metastases
3.no prior pancreas resection
4. no prior cytostatic chemotherapy
5. Male and female patients aged = 18 and = 75 years
6. ECOG = 1
7. medical operability
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126
1. Endocrine pancreas carcinoma
2. Locally advanced inoperable stages
3. distant metastases
4. relapse
5. prior radiotherapy of the measurable lesions
6. Peritoneal carcinomatosis
7. Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
8. contraindication to operative resection
9. ECOG = 2
10. Severe hepatic impairment (AST/ALT>3,5xULN, AP>6xULN)
11. transhepatic drainage
12. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure and EF < 45%
13. severe internal diseases or acute infection
14. chronic diarrhea
15. chronic inflammatory bowel disease
16. Peripheral polyneuropathy > NCI grade II
17. Pregnancy or lactation
18. hypersensitivity or contraindication to Gemcitabine, Oxaliplatin, Natrium folinate, Irinotecan, 5-Fluorouracil
19. Participation in another interventional study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: overall survival;Secondary Objective: Progression-free survival (PFS)<br>R0 resection rate<br>perioperative 30-day morbidity <br>pathological complete remission<br>feasibility and safety of perioperative Folfirinox regarding prophylactic use of G-CSF<br>prevalence of iron deficiency anemia during perioperative therapy;Primary end point(s): median overall survival;Timepoint(s) of evaluation of this end point: continuously
- Secondary Outcome Measures
Name Time Method Secondary end point(s): progression free survival (PFS)<br>R0 resection rate<br>perioperative 30-day morbidity <br>pathological complete remission<br>feasibility and safety of perioperative Folfirinox regarding prophylactic use of G-CSF<br>prevalence of iron deficiency anemia during perioperative therapy;Timepoint(s) of evaluation of this end point: PFS, safety: continuously<br>R0 resection rate: after surgery<br>perioperative 30-day morbidity: 30 days after surgery<br>iron deficiency: day 1 of every cycle<br>