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

January 12, 2010
January 12, 2010
November 2006
June 2008   (final data collection date for primary outcome measure)
To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety
Same as current
No Changes Posted
  • 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)
Same as current
Not Provided
Not Provided
 
Partial Liver Radiotherapy for Unresectable Liver Metastases
Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases

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.

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.

Interventional
Not Provided
Primary Purpose: Treatment
Metastatic Colorectal Liver Cancer
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Diana Tait 020 8661 8915
Contact: Maria Hawkins 020 8661 8915
United Kingdom
 
NCT01048216
CCR2772
Not Provided
Dr Diana Tait, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: Diana Tait Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP