A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy

Phase 3

Recruiting

• Conditions: pancreatic cancer; pancreatic ductal adenocarcinoma; 10027656

• Registration Number: NL-OMON55290
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

PACAP-participants with isolated local PDAC recurrence are eligible for
randomization if they meet all of the following criteria:
- Isolated local PDAC recurrence after primary resection;
- ECOG performance score 0-2;
- Written informed consent for being randomized in future studies.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Age < 18 years;
- Distant metastases;
- Expected lifespan < 3 months;
- Ineligibility for MRI or CT according to the protocol of the local radiology
department;
- Highly selective cases with resectable, isolated local recurrence without the
need for either systemic or local ablative induction therapy, eligible for
re-resection according to the expert panel.
- Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primarily, the effect of SBRT in addition to standard of care compared to<br /><br>standard of care alone on survival after recurrence is<br /><br>investigated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are: patient-reported quality of life, treatment response<br /><br>assessed by CT-imaging, acute and late toxicity,<br /><br>overall survival, progression-free survival, local progression-free survival,<br /><br>distant metastasis free survival.</p><br>