Partial Liver Radiotherapy for Unresectable Liver Metastases

Not Applicable

• Conditions: Metastatic Colorectal Liver Cancer

• Registration Number: NCT01048216
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Last Update Submitted: 2010-01-12
• Study First Posted: 2010-01-13
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom