Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer

Study Overview
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Brief Summary
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Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

Detailed Description
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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.

Official Title
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Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial

Conditions
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Pancreatic Adenocarcinoma

Intervention / Treatment
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* Radiation: neoadjuvant RTx
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant RTx<br> | Radiation: neoadjuvant RTx<br>* Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.<br>* Other names: Intensity modulated beam radiation (IMBR).;|
| Active Comparator: Surgery<br> | Procedure: Surgery<br>* Surgery and adjuvant chemotherapy according to German S3-guidelines<br>* Other names: Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival |  | At 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Adenocarcinoma, Neoadjuvant Radiotherapy