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Fractionated Stereotactic Radiosurgery for Large Brain Metastases

This study is currently recruiting participants.
Verified April 2017 by Dwight Heron, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02054689
First Posted: February 4, 2014
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh
  Purpose
This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.

Condition Intervention Phase
Large Brain Mets Radiation: Fractionated Stereotactic Radiosurgery Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES

Further study details as provided by Dwight Heron, University of Pittsburgh:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: 3 years ]
    Measured by any patients toxicities Performance status Quality of life

  • Safety of fractionated SRS [ Time Frame: 3 years ]
    Measured by patient toxicities


Secondary Outcome Measures:
  • Local control of the disease [ Time Frame: 3 years ]
    Measured by MRI


Estimated Enrollment: 25
Study Start Date: July 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fractionated Stereotactic Radiosurgery
24 to 36 Gy in 3 fractions (8-12 Gy/fx).
Radiation: Fractionated Stereotactic Radiosurgery
SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
Other Names:
  • SRS
  • SBRT
  • CyberKnife
  • Trilogy
  • True Beam
  • Radiosurgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age
  • A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
  • The target lesion(s) can be accurately measured in at least one dimension according to RECIST
  • No prior radiotherapy to the brain
  • Previous or concurrent systemic or targeted chemotherapy is allowed.
  • Patients must have an extra-cranial primary tumor diagnosis
  • Patients will have no more than 3 distinct lesions within the brain.
  • At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
  • The additional lesions will each be treated with single fraction stereotactic radiosurgery
  • Patient may be on steroids or anti-epileptics
  • Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
  • Patients do not need a histologically proven diagnosis of brain mets

Exclusion Criteria:

  • Symptomatic patients in need of surgery to the "target" lesion
  • Four or more newly-diagnosed lesions
  • Prior surgical resection of targeted tumor
  • Prior WBRT
  • Primary brain tumor
  • Pregnant or breast-feeding patients
  • Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054689


Contacts
Contact: Karen D Holeva, BS 412-623-1275 holevakd@upmc.edu

Locations
United States, Pennsylvania
UPMC Shadyside Radiation Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Karen D Holeva, BS    412-623-1275    holevakd@upmc.edu   
Contact: Dwight E Heron, MD    412-623-6720    herond2@upmc.edu   
Sub-Investigator: Steven Burton, MD         
Sub-Investigator: David A Clump, MD, PhD         
Sub-Investigator: John Flickinger, MD         
Sub-Investigator: Johnathan Engh, MD         
Sub-Investigator: Nduka Amankulor, MD         
Principal Investigator: Dwight E Heron, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dwight E Heron, MD University of Pittsburgh
  More Information

Responsible Party: Dwight Heron, Vice Chairman of Clinical Affairs, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02054689     History of Changes
Other Study ID Numbers: 11-091
First Submitted: January 30, 2014
First Posted: February 4, 2014
Last Update Posted: April 25, 2017
Last Verified: April 2017