De (kosten)effectiviteit van neoadjuvante FOLFIRINOX versus neoadjuvante chemoradiotherapie met gemcitabine en adjuvante gemcitabine voor patiënten met (borderline) resectabel pancreaskanker - PREOPANC-2 studie
Completed
- Conditions
- Resectable pancreatic ductal adenocarcinoma, Borderline resectable pancreatic ductal adenocarcinoma
- Registration Number
- NL-OMON28312
- Lead Sponsor
- Erasmus MC University Medical Center, Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 368
Inclusion Criteria
• Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma)
• (Borderline) resectable tumor without metastatic disease* (DPCG definitions of resectability)
Exclusion Criteria
• Prior radiotherapy, chemotherapy, or resection for pancreatic cancer.
• Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method To compare between the study arms:<br /><br>• Chemotherapy rate<br /><br>• Chemotherapy completion rate<br /><br>• Staging laparoscopy rate<br /><br>• Laparoscopy yield<br /><br>• Exploratory laparotomy rate<br /><br>• Resection rate<br /><br>• R0 resection rate<br /><br>• Progression free survival (PFS)<br /><br>• Locoregional failure free interval (LFFI)<br /><br>• Distant metastases free interval (DMFI)<br /><br>• Disease free survival (DFS)<br /><br>• Locoregional recurrence free interval (LRFI)<br /><br>• Postoperative complications<br /><br>• Toxicity<br /><br>• Quality of life years (QALYs)<br /><br>• Indirect and direct medical and nonmedical costs<br /><br>• Clinical response rate defined according to RECIST criteria<br /><br>• Serum Cancer Antigen 19-9 (CA 19.9) and Carcino-Embryonal-Antigen (CEA) response<br /><br>• Pathologic response