Pancreatic Adenocarcinoma
Conditions
Keywords
Pancreatic Cancer, Adenocarcinoma, Neoadjuvant Radiotherapy
Brief summary
Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.
Detailed description
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.
Interventions
RADIATIONneoadjuvant RTx
Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.
PROCEDURESurgery
Surgery and adjuvant chemotherapy according to German S3-guidelines
Sponsors
Technical University of Munich
CHIR-Net
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the pancreatic head * Age ≥ 18 years * Signed informed consent * ECOG performance status of 0-2
Exclusion criteria
* Curative resection is not feasible or presence of metastatic disease * Patients not eligible for surgery (ASA ≥ 4) * Participation in an other clinical trial * Unable or unwilling to sign the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local recurrence free survival | At 12 months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day morbidity and mortality | 30 day period after the operation | — |
| Toxicity of preoperative Radiotherapy | Start of the radiotherapy until 12 months postoperative. | 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 |
| Clinical response rate (RECIST-criteria) and histological response rate | Until 1 year postOP | — |
| Percentage of surgical R0-resections in both groups | Until 10 days postoperative | Determined by histopathological analysis of the surgical specimen. |
| Quality of life | Until 12 months postoperative | — |
| Overall survival after 1 year | Until 1 year postoperative | — |
| Time to tumor progression (local and systemic) | Until 1 year postoperative | — |
Countries
Germany
Outcome results
None listed