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Partial Liver Radiotherapy for Unresectable Liver Metastases

Primary Purpose

Metastatic Colorectal Liver Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Liver Cancer focused on measuring colorectal liver cancer, metastatic, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Marsden NHS Foundation TrustRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
January 12, 2010
Last Updated
January 12, 2010
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01048216
Brief Title
Partial Liver Radiotherapy for Unresectable Liver Metastases
Official Title
Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Liver Cancer
Keywords
colorectal liver cancer, metastatic, radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety
Secondary Outcome Measure Information:
Title
To evaluate local control rate within irradiated fields
Title
To assess failure patterns and survival of patients treated with conformal liver radiation
Title
Set up verification with cone-beam CT (OBI on Boar Imager)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Tait
Phone
020 8661 8915
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Hawkins
Phone
020 8661 8915
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Tait
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Hawkins
Phone
020 8661 8915
First Name & Middle Initial & Last Name & Degree
Diana Tait

12. IPD Sharing Statement

Learn more about this trial

Partial Liver Radiotherapy for Unresectable Liver Metastases

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