Partial Liver Radiotherapy for Unresectable Liver Metastases

Metastatic Colorectal Liver Cancer Clinical Trial

Official title:

Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01048216
• Other study ID #: CCR2772
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: November 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2010
• Source: Royal Marsden NHS Foundation Trust
• Contact: Diana Tait
• Phone: 020 8661 8915
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Metastatic Colorectal Liver Cancer

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety
Secondary	To evaluate local control rate within irradiated fields
Secondary	To assess failure patterns and survival of patients treated with conformal liver radiation
Secondary	Set up verification with cone-beam CT (OBI on Boar Imager)