PELICAN trial; local ablative treatment of an inoperable pancreascarcinoma; lokale verbranding van een niet-operabel alvleeskliertumor

Recruiting

• Conditions: stage III; RFA; Pancreatic cancer; radiofrequency ablation; treatment; pancreascarcinoma; inoperable; locally irresectable

• Registration Number: NL-OMON27800
• Lead Sponsor: Olympus Medical Systems: CelonPowerSystem; CelonProSurge probes

Brief Summary

not yet

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 228

Inclusion Criteria

1.Histologically or cytologically confirmed adenocarcinoma of the pancreas

2.Locally irresectable tumor (according to the Dutch Pancreatic Cancer Group criteria; www.dpcg.nl)

Exclusion Criteria

1.WHO performance status ≥ 3

2.Distant metastases on abdominal or thoracic CT scan*

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
1.Clinical<br /><br>•Postoperative complications<br /><br>•Toxicity of post-randomization chemotherapy<br /><br>•Visual Analogue Scale (VAS) pain score<br /><br>•Symptom free survival<br /><br>2.Pathophysiological<br /><br>•Objective Tumor Response (RECIST criteria [38,39])<br /><br>•Progression free survival (RECIST criteria [38,39])<br /><br>•CA 19-9 & CEA response<br /><br>•Immunomodulating factors<br /><br>3.Additional:<br /><br>•Time between randomization and start of study treatment<br /><br>•Quality of life as measured by validated questionnaires<br /><br>•Indirect and direct health costs