Partial Liver Radiotherapy for Unresectable Liver Metastases

Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01048216

Enrollment

Registered

2010-01-13

Start date

2006-11-30

Completion date

2008-06-30

Last updated

2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Liver Cancer

Keywords

colorectal liver cancer, metastatic, radiation therapy

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.

Interventions

RADIATIONradiation 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

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety	—

Secondary

Measure	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)	—

Countries

United Kingdom

Contacts

Primary ContactDiana Tait

020 8661 8915

Backup ContactMaria Hawkins