Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer
|ClinicalTrials.gov Identifier: NCT00607828|
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : September 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Radiation: stereotactic body radiation therapy||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||February 15, 2017|
Radiation: stereotactic body radiation therapy
- Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 1 month after SRT ]
- Maximum tolerated dose [ Time Frame: At least 1 month of observation after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607828
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Principal Investigator:||Chi Lin, MD, PhD||University of Nebraska|