N/A N=128 Treatment

A Study For Using Radiosurgery On Limited Metastases

Neoplasms, Metastatic

Bottom Line

View on ClinicalTrials.gov: NCT00178399 ↗

Enrolled (actual)

128

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Percentage of Curatively Treated Patients With Progression-free Survival — 16 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stereotactic Body Radiation Therapy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Mar 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Curatively Treated Patients With Progression-free Survival	16	—
PRIMARY Percentage of Palliatively Treated Patients With Progression-free Survival	38	—
SECONDARY Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles	—	—
SECONDARY Analyze Impact of Disease Bulk and Number of Sites Involved.	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00178399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.