A Pilot Study For Using Radiosurgery On Limited Metastases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- Percentage of Curatively Treated Patients With Progression-free Survival
Study Overview
Brief Summary
The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. A second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.
Detailed Description
In this research study high dose stereotactic body radiation therapy will be 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. Blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. Two to four tablespoons of blood will be removed each time.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria.
- •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. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements.
- •Informed consent must be obtained.
- •Pregnancy test must be negative for women of child bearing potential.
- •Out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. The secondary aim (blood cytokines) is optional for out-of-state patients.
Exclusion Criteria
- •Technical inability to achieve required dose based on safe dose constraints required for radiosurgery
- •Women who are pregnant or nursing..
- •Failure to meet inclusion requirements
- •Contraindications to radiation.
- •Patient should not be eligible for primary disease specific radiosurgical protocols
Arms & Interventions
Stereotactic body radiation therapy
Intervention: Stereotactic Body Radiation Therapy (Procedure)
Outcomes
Primary Outcomes
Percentage of Curatively Treated Patients With Progression-free Survival
Time Frame: 24 months
Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
Percentage of Palliatively Treated Patients With Progression-free Survival
Time Frame: 24 months
Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
Secondary Outcomes
- Analyze Impact of Disease Bulk and Number of Sites Involved.(From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years)
- Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles(30 months from date of registration.)
Investigators
Michael Milano, MD,PhD
Associate Professor
University of Rochester