N/A
N=49
Study for Using Radiosurgery on Limited Metastases of Breast Cancer
Breast Cancer, Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT00167414 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Overall Survival — 74 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypofractionated Stereotactic Body Radiation Therapy (Procedure); Hypofractionated Stereotactic Body Radiation Therapy (Radiation)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
47 | — |
| PRIMARY Overall Survival |
47 | — |
| PRIMARY Overall Survival |
47 | — |
| SECONDARY Percent of Patients With Lesion Local Control |
87 | — |
| SECONDARY Number of Participants Who Experienced a Grade 4 or 5 Toxicity |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age: no limit
- Karnofsky performance status (KPS) ≥ 70
- No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).
- The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.
- Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.
- Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.
- Informed consent must be obtained.
- Pregnancy test must be negative for women of child bearing potential
Exclusion Criteria
- Inability of patient to be followed longitudinally as specified by protocol.
- Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.
- Women who are pregnant or nursing.
- Failure to meet requirements in Inclusion Criteria
- Contraindications to radiation.
Data sourced from ClinicalTrials.gov (NCT00167414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.