Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a standardized surveillance strategy - an international randomized controlled trial by the Dutch Pancreatic Cancer Group

Recruiting

Conditions: pancreatic cancer
pancreatic ductal adenocarcinoma
10017991

Registration Number: NL-OMON56087

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

- Histologically confirmed macroscopically radical resected (R0-R1) pancreatic
adenocarcinoma
- Age >= 18 years
- Written informed consent for being randomized in future studies

Exclusion Criteria

- Exclusion criteria for contrast-enhanced CT scan, following the protocol of
the department of radiology in each DPCG affiliated hospital
- Mentally or physically incapable of consent
- Participation in other DPCG studies with a study-specific follow-up

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is overall survival after primary resection of PDAC,<br /><br>designated as the time from the date of surgery until either death from any<br /><br>cause or last follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives of this study are:<br /><br>• Quality of Life<br /><br>• Compliance to a standardized surveillance strategy<br /><br>• Recurrence-free interval<br /><br>• Clinical and radiological patterns of PDAC recurrence<br /><br>• Prognostic factors for PDAC recurrence<br /><br>• Role of serum tumor marker testing in detecting recurrent PDAC<br /><br>• Eligibility for additional (experimental) treatment at time of recurrence<br /><br>diagnosis<br /><br>• Reasons to abandon treatment for recurrence (i.e. eligibility, deteriorated<br /><br>condition, patients wish, doctors advice etc.)<br /><br>• Tolerance of additional treatment for recurrent PDAC<br /><br>• Morbidity associated with diagnostic testing<br /><br>• Costs</p><br>