A Study For Using Radiosurgery On Limited Metastases

Not Applicable

Completed

Conditions: Neoplasms, Metastatic

Interventions: Procedure: Stereotactic Body Radiation Therapy

Registration Number: NCT00178399

Lead Sponsor: University of Rochester

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic body radiation therapy	Stereotactic Body Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.