A Study For Using Radiosurgery On Limited Metastases

A Pilot 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.

Study Overview

• Status: Completed
• Conditions: Neoplasms, Metastatic
• Intervention / Treatment: Procedure: Stereotactic Body Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Department of Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic body radiation therapy	Procedure: Stereotactic Body Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Curatively Treated Patients With Progression-free Survival	Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.	24 months
Percentage of Palliatively Treated Patients With Progression-free Survival	Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles	Correlation of data from QOL questionnaires and blood markers.	30 months from date of registration.
Analyze Impact of Disease Bulk and Number of Sites Involved.	Analysis or response and progression.	From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Michael Milano, MD PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2001
• Primary Completion (Actual): March 15, 2007
• Study Completion (Actual): March 15, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: URCC 9700