Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
|ClinicalTrials.gov Identifier: NCT00567970|
Recruitment Status : Active, not recruiting
First Posted : December 5, 2007
Last Update Posted : November 17, 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 liver metastases.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Procedure: quality-of-life assessment Radiation: stereotactic body radiation therapy||Phase 1|
- To identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases.
- To determine the toxicity and adverse events profile of this patient population.
- To examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population.
OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs > 5).
Patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement.
Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment.
After completion of study treatment, patients are followed for at least 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Official Title:||A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis|
|Actual Study Start Date :||April 2007|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
- Maximum tolerated dose
- Toxicity profile
- Adverse events profile
- Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
- Response profile
- Physical exam results
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567970
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Laura A. Vallow, MD||Mayo Clinic|