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

Phase 2

Terminated

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Tomotherapy	Tomotherapy treatment	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.

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate (Complete Response + Partial Response).	1 year

Secondary Outcome Measures

Name	Time	Method
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