Partial Liver Radiotherapy for Unresectable Liver Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-06-30

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.

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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.

Conditions

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Metastatic Colorectal Liver Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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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

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No