Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors

Study Overview
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Brief Summary
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Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation

Official Title
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A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors

Conditions
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Liver Tumors

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically conformation of liver malignancy Solitary or multiple liver tumors amenable to SBRT No jaundice or liver dysfunction For metastases, the primary tumor site has been adequately treated. For primary hepatoma, no extra-hepatic disease Karnofsky > 70 Exclusion Criteria: no extra-hepatic disease Liver failure or inadequate liver function Ascites Previous radiation therapy to the liver lesions invading major blood vessels in the porta region Contraindication to receive radiation therapy in the liver

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Eligible patient will be treated with 48 Gy in 4 fractions encompassing the entire target lesion in 2 weeks with a minimum of 48 hours between each dose. | Radiation: Stereotactic Body Radiation Therapy<br>* Radiation Dose: 48 Gy in 4 fractions in 2 weeks. A minimum of 48 hours should separate each treatment (e.g. every Tuesday and Friday). The dose is prescribed to the marginal isodose (80-90%) that encompasses the entire target lesion (GTV). Treatment will be delivered using a linear accelerator. For verification of the accuracy of these external skin fiducial markers, 10 patients will also have implanted internal gold coil markers. The implantable gold coil markers will be implanted into the liver in the proximity of the target lesions via a percutaneous transhepatic route under fluoroscopy guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate to SBRT |  | 3-6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Related Toxicity |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver malignancy, Stereotactic Body Radiation Therapy, Efficacy of SBRT in liver tumors, Hepatic toxicity with SBRT