Cone-beam CT guided Stereotactic Radiation Therapy for Locally Advanced and Locally Recurrent Pancreatic Cancer
Phase 2
Completed
- Conditions
- pancreatic cancer100179901001981510019818
- Registration Number
- NL-OMON43956
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
* Pancreatic cancer:
- Primary unresectable pancreatic tumors according to Dutch Pancreatic Cancer Group; or
- Medically inoperable patients with pancreatic cancer; or
- Isolated locally recurrent pancreatic cancer.
* *18 years.
* Written informed consent.
Exclusion Criteria
* Evidence of distant metastasis.
* WHO performance status 3-4.
* Expected life span <3 months.
* Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint will be safety of the procedure, expressed in<br /><br>proportion of patients experiencing treatment-induced toxicity grade 3 or more<br /><br>according to the CTC-AE 4.0 due to the complete procedure within 90 days of the<br /><br>last irradiation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Other study parameters will be technical feasibility, treatment response,<br /><br>quality of life, overall survival, progression free survival, and rate of<br /><br>possible secondary resections.</p><br>