Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer
Recruitment status was Recruiting
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with advanced liver cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma|
- Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 1 month after SRT ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose [ Time Frame: At least 1 month of observation after surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Radiation: stereotactic body radiation therapy
- To determine the safety of hypofractionated stereotactic radiotherapy (SRT) in patients with advanced hepatocellular carcinoma.
- To determine the maximum tolerated dose of SRT in these patients.
- To determine the objective tumor response rate in terms of the percentage of tumor size change on CT, percentage of intensity change on MRI, and the percentage of change in alfa fetoprotein in patients treated with this therapy.
- To determine the value of 4-dimensional CT in liver cancer planning in terms of the extent of liver motion (three dimensionally) and the percentage of patients requiring breath gating due to the amplitude of organ motion exceeding 1 cm in any dimension.
- To determine the value of breath gating in liver cancer SRT in terms of the success rate of breath gating and the percentage of treatment time prolongation secondary to the gating.
OUTLINE: Patients undergo hypofractionated stereotactic radiotherapy once daily on days 1-5.
After completion of study therapy, patients are followed at 1 and 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607828
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198-6805|
|Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465|
|Principal Investigator:||Chi Lin, MD, PhD||University of Nebraska|