Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer (Net-Pac)
Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.
Radiation: neoadjuvant RTx
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial|
- Local recurrence free survival [ Time Frame: At 12 months postoperative ] [ Designated as safety issue: No ]
- Percentage of surgical R0-resections in both groups [ Time Frame: Until 10 days postoperative ] [ Designated as safety issue: No ]Determined by histopathological analysis of the surgical specimen.
- 30-day morbidity and mortality [ Time Frame: 30 day period after the operation ] [ Designated as safety issue: Yes ]
- Toxicity of preoperative Radiotherapy [ Time Frame: Start of the radiotherapy until 12 months postoperative. ] [ Designated as safety issue: Yes ]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 [ Time Frame: Until 1 year postOP ] [ Designated as safety issue: Yes ]
- Time to tumor progression (local and systemic) [ Time Frame: Until 1 year postoperative ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Until 12 months postoperative ] [ Designated as safety issue: Yes ]
- Overall survival after 1 year [ Time Frame: Until 1 year postoperative ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Experimental: Neoadjuvant RTx||
Radiation: neoadjuvant RTx
Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.
Other Name: Intensity modulated beam radiation (IMBR).
|Active Comparator: Surgery||
Surgery and adjuvant chemotherapy according to German S3-guidelines
Other Name: Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple
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.
|Contact: Andre L Mihaljevic, MD M.Sc.||+49 (0)89 4140 firstname.lastname@example.org|
|Contact: Michael Kranzfelder, MD||+49 (0)89 4140 email@example.com|
|Klinikum rechts der Isar, Technische Universität München||Not yet recruiting|
|Munich, Germany, 81675|
|Contact: Andre L Mihaljevic, MD M.Sc. +49 (0)89 4140 5145 firstname.lastname@example.org|
|Principal Investigator: Helmut M Friess, Prof. MD|
|Principal Investigator: Michael Molls, Prof. MD|
|Sub-Investigator: Hans Geinitz, PD MD|
|Sub-Investigator: Michael Kranzfelder, MD|
|Sub-Investigator: Andre Mihaljevic, MD|
|Sub-Investigator: Peter Buechler, MD|
|Principal Investigator:||Helmut M Friess, Prof. MD||Technische Universität München|
|Study Director:||Michael Molls, Prof. MD||Technische Universität München|