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2011-10
2014-10
2014-10
5
NCT01419002
CHIR-Net
CHIR-Net
INTERVENTIONAL
Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-08-13 | N/A | 2015-07-27 |
2011-08-16 | N/A | 2015-07-29 |
2011-08-17 | N/A | 2015-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Neoadjuvant RTx | RADIATION: neoadjuvant RTx
|
| ACTIVE_COMPARATOR: Surgery | PROCEDURE: Surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Local recurrence free survival | At 12 months postoperative |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
