Fractionated Stereotactic Radiosurgery for Large Brain Metastases

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. Identifier: NCT02054689
Recruitment Status : Recruiting
First Posted : February 4, 2014
Last Update Posted : January 29, 2018
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Large Brain Mets Radiation: Fractionated Stereotactic Radiosurgery Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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

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

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02054689

Contact: Karen D Holeva, BS 412-623-1275

United States, Pennsylvania
UPMC Shadyside Radiation Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Karen D Holeva, BS    412-623-1275   
Contact: Dwight E Heron, MD    412-623-6720   
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
Principal Investigator: Dwight E Heron, MD University of Pittsburgh

Responsible Party: Dwight Heron, Vice Chairman of Clinical Affairs, University of Pittsburgh Identifier: NCT02054689     History of Changes
Other Study ID Numbers: 11-091
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018