Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases|
- The maximum tolerated dose of single fraction stereotactic radiotherapy in patients with hepatic metastases. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]The dose of single fraction stereotactic radiotherapy will be escalated without exceeding the maximum tolerated dose in patients with hepatic metastases.
- The dose-limiting toxicity. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- The actual 6 and 12 month local control rates [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- An optimal therapeutic window between control and toxicity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- The 3 month tumor response rate [ Time Frame: 3 month ] [ Designated as safety issue: No ]
- The survival rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 35Gy in one fraction. Subsequent cohorts of patients will receive an additional 5Gy per treatment to a maximum planned dose of 50Gy in one fraction.
Single fraction SBRT
Other Name: Stereotactic Body Radiation Therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162278
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Jeffrey Meyer, MD||The University of Texas Southwestern Medical Center at Dallas|