Partial Liver Radiotherapy for Unresectable Liver Metastases

Study Overview
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Brief Summary
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This study is designed to treat tumors in the liver that cannot be removed surgically and chemotherapy cannot control these tumors, using radiation therapy and a more precise delivery than has been used before.

Detailed Description
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The purpose of this study is to evaluate safety and feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer. This study would also evaluate local control rate within irradiated area and to assess failure patterns and survival of patients treated with conformal liver radiation.

Official Title
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Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases

Conditions
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Metastatic Colorectal Liver Cancer

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: liver metastases unequivocally seen on contrast enhanced CT and/or MRI from colon or rectal cancer, previously confirmed pathologically as adenocarcinoma either 1) the tumor must be unresectable, 2) the patient must be medically inoperable, or 3) extra-hepatic metastases are present (making hepatic surgery an inappropriate treatment option) good performance status (0-1) Age > 18 years. Adult patients of all ages, both sexes and all races will be included in this study. Female patients within reproductive years may not be, nor become, pregnant during participation in this study life expectancy > 3 months Exclusion Criteria: patients with active hepatitis or clinically significant liver failure patients receiving anticoagulation treatment with warfarin or heparin prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver clinically apparent ascites central nervous system metastases

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiation therapy|CT based 3D treatment shall be used for all patients. There will be 10 equal fractions delivered over 2 weeks. The prescribed dose and fraction will be individualised according to effective liver volume treated|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate local control rate within irradiated fields |  |  | 
| To assess failure patterns and survival of patients treated with conformal liver radiation |  |  | 
| Set up verification with cone-beam CT (OBI on Boar Imager) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal liver cancer, metastatic, radiation therapy