Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.

Detailed Description
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Objective of the study: To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma Study design: Pilot study to determine safety and feasibility Study population: Patients with locally advanced pancreatic carcinoma, without distant metastasis Intervention: Patients will undergo endoscopic fiducial marker placement, and patients will get a custom-made individual corset. Radiotherapy will be delivered in three fractions of 8 Gy on an outpatient basis. Primary study outcome: 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 radiation. Secondary study outcome: Other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Increased severe toxicity may occur due to the intervention, but treatment related toxicity should be limited due to strict dose constraints to the organs at risk (e.g. duodenum, stomach). Potential benefits may be pain relief, due to local control of the tumor, and a prolonged survival.

Official Title
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Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: 24 Gy in 3 fractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced pancreatic tumors (stage III) or medically inoperable patients with pancreatic cancer (stage I, II, or III) Not eligible for operation with curative intent >18 years Written informed consent Exclusion Criteria: WHO performance status 3-4 Expected life span <3 months Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: irradiation<br>24 Gy in 3 fractions | Radiation: 24 Gy in 3 fractions<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | 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 radiation | 90 days of last irradiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, Pancreatic cancer, Radiotherapy