NCT01162278

Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health \& Hospital System, and Methodist Richardson Cancer Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7 to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last for approximately 1 day and the follow-up portion of the study will last 5 years.

Detailed description

If the patient has met all the eligibility criteria, they will be registered to the study After successful registration to the study and treatment planning session, patients will receive a single fraction of radiation. The total dose a particular patient receives will depend on the dose cohort they are enrolled into. Each treatment will last about one hour and will be given in a particular position to help guide the beams of radiation toward the cancer area. Although it is not mandatory, it is recommended that patients receive corticosteroid premedication (e.g. Decadron 4-10 m.g. p.o. in a single dose or equivalent) 15-60 minutes prior to each treatment for the intended purpose of modulating immediate acute inflammatory effects and providing anti-emetic support.

Conditions

• Liver Metastases

Interventions

Type	Name	Description
RADIATION	SBRT	Single fraction SBRT

Timeline

• Start date: 2010-07-01
• Primary completion: 2015-11-25
• Completion: 2017-11-25
• First posted: 2010-07-14
• Last updated: 2020-08-20

Locations

1 site across 1 country: United States