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Partial Liver Radiotherapy for Unresectable Liver Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01048216
First received: January 12, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  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:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Diana Tait, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01048216     History of Changes
Other Study ID Numbers: CCR2772
Study First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013