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| Sponsor: | University of Rochester |
|---|---|
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00178399 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Neoplasms, Metastatic |
Procedure: Stereotactic Body Radiation Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study For Using Radiosurgery On Limited Metastases |
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | April 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, New York | |
| University of Rochester Department of Radiation Oncology | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Paul Okunieff, MD | University of Rochester |
More Information
| Responsible Party: | Michael Milano, MD PhD, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00178399 History of Changes |
| Other Study ID Numbers: | URCC 9700 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 28, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
