A Pilot Study For Using Radiosurgery On Limited Metastases
18 Years
N/A
Both
Neoplasms, Metastatic
Trial Information
A Pilot Study For Using Radiosurgery On Limited Metastases
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the feasibility and potential utility of radiosurgery for limited metastatic disease, compared to historical controls.
Principal Investigator
Paul Okunieff, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Rochester
Authority:
United States: Institutional Review Board
Study ID:
URCC 9700
NCT ID:
NCT00178399
Start Date:
April 2001
Completion Date:
April 2006
Related Keywords:
- Neoplasms, Metastatic
- Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of Rochester Department of Radiation Oncology | Rochester, New York 14642 |
