Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver|
- Tumor Response Rate (Complete Response + Partial Response). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Radiation: Tomotherapy treatment
The purpose of this study is to determine the response of liver tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety. The usual treatment for this type of disease for patients who are eligible is surgery to remove the tumors. For patients who aren't eligible for surgery or who chose not to have surgery, they are treated with low daily doses of radiation given over many weeks; however this type of treatment has not been very effective.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030757
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Ben Liem, MD||University of New Mexico Cancer Center|