Department of Radiation Oncology: University of Rochester
Rochester, New York, 14642, United States
NCT Number: NCT00167414
The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.
Looking for future studies?
Notify MeFemale
Interventional
Not applicable
Rochester, New York, 14642, United States
Before treatment begins, you will have a physical exam and blood tests. Physical evaluations and blood tests will be done each week while you are receiving treatment, and at follow-up visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and every three months thereafter. You will be asked to fill out a Quality of Life questionnaire, which should take 5-10 minutes to complete. This will be done prior to treatment and at your follow-up visits. You will receive high dose radiation therapy directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hypofractionated Stereotactic Body Radiation Therapy
Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Time frame: 2 years
The percent of patients that survived from date of enrollment until 2 year follow-up visit.
Time frame: 4 years
The percent of patients that survived from date of enrollment until 4 year follow-up visit
Time frame: 6 years
The percent of patients that survived from date of enrollment until 6 year follow-up visit
Time frame: 6 years
Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.
Time frame: 6 years
Number of participants who experienced a grade 4 or 5 toxicity
University of Rochester
Other
A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03427450
Breast Cancer, Metastatic, Breast Diseases
Los Angeles, California, United States
View Trial DetailsNCT00044525
Breast Cancer, Metastatic, Breast Diseases
Stuttgart, Baden-Wurttemberg, Germany
View Trial DetailsNCT00288249
Breast Cancer, Metastatic, Breast Diseases
Vienna, State of Vienna, Austria
View Trial DetailsNCT01045304
Breast Cancer, Metastatic, Breast Diseases
Parkville, Australia
View Trial Details