Clinical trial NCT00178399: A Study For Using Radiosurgery On Limited Metastases
Official title: A Pilot Study For Using Radiosurgery On Limited Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms, Metastatic
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Curatively Treated Patients With Progression-free Survival
timeFrame: 24 months
measure: Percentage of Palliatively Treated Patients With Progression-free Survival
timeFrame: 24 months
Secondary outcomes:
measure: Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles
timeFrame: 30 months from date of registration.
measure: Analyze Impact of Disease Bulk and Number of Sites Involved.
timeFrame: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Department of Radiation Oncology
state: New York
Study officials:
affiliation: University of Rochester
name: Michael Milano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: