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Partial Liver Radiotherapy for Unresectable Liver Metastases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01048216
First Posted: January 13, 2010
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Marsden NHS Foundation Trust
  Purpose
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.

Condition Intervention
Metastatic Colorectal Liver Cancer Radiation: radiation therapy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

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)

Estimated Enrollment: 18
Study Start Date: November 2006
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048216


Contacts
Contact: Diana Tait 020 8661 8915
Contact: Maria Hawkins 020 8661 8915

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Maria Hawkins    020 8661 8915      
Principal Investigator: Diana Tait         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Diana Tait Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Dr Diana Tait, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01048216     History of Changes
Other Study ID Numbers: CCR2772
First Submitted: January 12, 2010
First Posted: January 13, 2010
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by Royal Marsden NHS Foundation Trust:
colorectal liver cancer
metastatic
radiation therapy

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases