Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.
The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.
Surgery and adjuvant chemotherapy according to German S3-guidelines
Klinikum rechts der Isar, Technische Universität München
Munich, Germany
Local recurrence free survival
Time frame: At 12 months postoperative
Percentage of surgical R0-resections in both groups
Determined by histopathological analysis of the surgical specimen.
Time frame: Until 10 days postoperative
30-day morbidity and mortality
Time frame: 30 day period after the operation
Toxicity of preoperative Radiotherapy
Number of patients with adverse events in both groups, number of adverse events in both groups and number of grade 3 and 4 adverse events according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) in both groups
Time frame: Start of the radiotherapy until 12 months postoperative.
Clinical response rate (RECIST-criteria) and histological response rate
Time frame: Until 1 year postOP
Time to tumor progression (local and systemic)
Time frame: Until 1 year postoperative
Quality of life
Time frame: Until 12 months postoperative
Overall survival after 1 year
Time frame: Until 1 year postoperative
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