Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver

Study Overview
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Brief Summary
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The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.

Detailed Description
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The purpose of this study is to determine the response of liver tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety. The usual treatment for this type of disease for patients who are eligible is surgery to remove the tumors. For patients who aren't eligible for surgery or who chose not to have surgery, they are treated with low daily doses of radiation given over many weeks; however this type of treatment has not been very effective.

Official Title
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Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver

Conditions
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Liver Cancer

Intervention / Treatment
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* Radiation: Tomotherapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic confirmation of solid primary tumor metastatic to liver Age greater than or equal to 18 years old Zubrod performance status less than or equal to 1 Negative pregnancy test for women of child bearing potential Informed consent Less than or equal to 3 liver metastases Each lesion must be less than or equal to 6 cm in maximal diameter No prior radiation to lesions being treated Patient is not a surgical candidate or refuses surgery Absolute neutrophil count ≥ 1800 Platelets ≥ 100000 Hemoglobin ≥8.0 Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT At time of radiation treatment planning, at least 700 cc of normal liver must receive less than 15 Gy Exclusion Criteria: Contraindications to radiation Pregnant or lactating females who chose to breast feed Patients must have recovered from toxicity of prior therapy Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications Patients currently receiving anticoagulation with coumadin or IV heparin Liver cirrhosis Clinical ascites Bilirubin > 3, Albumin < 2.5, liver enzymes 3 times above normal, Creatinine > 1.8

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: Tomotherapy<br>Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV. | Radiation: Tomotherapy treatment<br>* A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours Dose will be prescribed to the isodose line which covers at least 90% of the PTV Dose homogeneity +/- 5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response Rate (Complete Response + Partial Response). |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cancer, Metastatic Liver Cancer, Tomotherapy, Stereotactic Body Radiation Therapy