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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|