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Completed

NCT Number: NCT00178399

A Study For Using Radiosurgery On Limited Metastases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Department of Radiation Oncology

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stereotactic body radiation therapy

Procedure

Primary outcomes

  1. Percentage of Curatively Treated Patients With Progression-free Survival

    Time frame: 24 months

    Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.

  2. Percentage of Palliatively Treated Patients With Progression-free Survival

    Time frame: 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 outcomes

  1. Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles

    Time frame: 30 months from date of registration.

    Correlation of data from QOL questionnaires and blood markers.

  2. Analyze Impact of Disease Bulk and Number of Sites Involved.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Pilot Study For Using Radiosurgery On Limited Metastases

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.