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lack of recruitment
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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant RTx | Experimental |
| |
| Surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant RTx | Radiation | Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence free survival | At 12 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of surgical R0-resections in both groups | Determined by histopathological analysis of the surgical specimen. | Until 10 days postoperative |
| 30-day morbidity and mortality | 30 day period after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helmut M Friess, Prof. MD | Technical University of Munich | Principal Investigator |
| Michael Molls, Prof. MD | Technical University of Munich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar, Technische Universität München | Munich | 81675 | Germany |
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| Label | URL |
|---|---|
| Department of Radiation Oncology, Technische Universität München | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
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| Surgery | Procedure | Surgery and adjuvant chemotherapy according to German S3-guidelines |
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| 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 | Start of the radiotherapy until 12 months postoperative. |
| Clinical response rate (RECIST-criteria) and histological response rate | Until 1 year postOP |
| Time to tumor progression (local and systemic) | Until 1 year postoperative |
| Quality of life | Until 12 months postoperative |
| Overall survival after 1 year | Until 1 year postoperative |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |