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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.
 
ClinicalTrials.gov Identifier: NCT02054689
Recruitment Status : Recruiting
First Posted : February 4, 2014
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Burton, 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
Study Start Date : July 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Locations
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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: Steve Burton, MD    412-623-6720    burtons@upmc.edu   
Sub-Investigator: David A Clump, MD, PhD         
Sub-Investigator: John Flickinger, MD         
Sub-Investigator: Johnathan Engh, MD         
Sub-Investigator: Nduka Amankulor, MD         
Principal Investigator: Steve Burton, MD         
Sponsors and Collaborators
Steven Burton
Investigators
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Principal Investigator: Dwight E Heron, MD University of Pittsburgh

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Responsible Party: Steven Burton, Clinical Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02054689    
Other Study ID Numbers: 11-091
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes