Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial
18 Years
N/A
Both
Pancreatic Adenocarcinoma
Trial Information
Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local recurrence free survival
Outcome Time Frame:
At 12 months postoperative
Safety Issue:
No
Principal Investigator
Helmut M Friess, Prof. MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Technische Universität München
Authority:
Germany: Federal Office for Radiation Protection
Study ID:
NetPac
NCT ID:
NCT01419002
Start Date:
October 2011
Completion Date:
April 2015
Related Keywords:
- Pancreatic Adenocarcinoma
- Pancreatic Cancer
- Adenocarcinoma
- Neoadjuvant Radiotherapy
- Adenocarcinoma
- Adenocarcinoma, Mucinous
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