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Cone-beam CT guided Stereotactic Radiation Therapy for Locally Advanced and Locally Recurrent Pancreatic Cancer

Cone-beam CT guided Stereotactic Radiation Therapy for Locally Advanced and Locally Recurrent Pancreatic Cancer - SBRT for pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43956
Enrollment
30
Registered
2013-05-15
Start date
2013-07-10
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

Pre-treatment, (recurrent) pancreatic cancer has to be pathology proven. Patients will undergo a contrast-enhanced CT scan, a contrast-enhanced MRI scan, endoscopic fiducial placement, and patients

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Evidence of distant metastasis. * WHO performance status 3-4. * Expected life span

Design outcomes

Primary

MeasureTime frame
The main study endpoint will be safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last irradiation.

Secondary

MeasureTime frame
Other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)