Neoplasms, Metastatic
Conditions
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.
Interventions
PROCEDUREStereotactic Body Radiation Therapy
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years KPS ≥ 70 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Curatively Treated Patients With Progression-free Survival | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles | 30 months from date of registration. | Correlation of data from QOL questionnaires and blood markers. |
| 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 | Analysis or response and progression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stereotactic Body Radiation Therapy Stereotactic Body Radiation Therapy | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Stereotactic Body Radiation Therapy |
|---|---|
| Age, Continuous | 60 years |
| Region of Enrollment United States | 128 Participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 123 / 128 |
| other Total, other adverse events | 24 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
Primary
Percentage of Curatively Treated Patients With Progression-free Survival
Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
Time frame: 24 months
Population: Only curative patients were included in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Body Radiation Therapy | Percentage of Curatively Treated Patients With Progression-free Survival | 16 percentage of participants |
Primary
Percentage of Palliatively Treated Patients With Progression-free Survival
Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
Time frame: 24 months
Population: Only palliative patients were included in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Body Radiation Therapy | Percentage of Palliatively Treated Patients With Progression-free Survival | 38 percentage of participants |
Secondary
Analyze Impact of Disease Bulk and Number of Sites Involved.
Analysis or response and progression.
Time frame: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years
Population: No data was collected for this outcome measure.
Secondary
Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles
Correlation of data from QOL questionnaires and blood markers.
Time frame: 30 months from date of registration.
Population: No data was collected for this outcome measure.