We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

This study is currently recruiting participants.
Verified April 2017 by Dwight Heron, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02514915
First Posted: August 4, 2015
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
The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.

Condition Intervention Phase
Malignant Neoplasm Brain Radiation: Stereotactic Radiosurgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

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

Primary Outcome Measures:
  • Local control rate in subjects with solitary brain metastases treated with pre-operative SRS followed by surgical resection [ Time Frame: 2 years ]
    Local control rate in subjects with solitary brain metastases treated with pre-operative SRS followed by surgical resection (as opposed to standard of care for surgical patients-either surgery followed by whole brain irradiation or surgery followed by SRS to the cavity). Only patients requiring surgical resection will be included in the study.


Secondary Outcome Measures:
  • Evaluate the overall survival with scans [ Time Frame: 2 years ]
  • Evaluate distant intracranial failure scans [ Time Frame: 2 years ]
  • Evaluate the subjects quality of life by Health Related Quality of Life (HRQL) Questionniare [ Time Frame: 2 years ]

Estimated Enrollment: 24
Study Start Date: February 2016
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stereotactic Radiosurgery
Subjects will receive stereotactic radiosurgery prior to resection
Radiation: Stereotactic Radiosurgery
Radiation therapy

Detailed Description:
Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.
  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:

  • Life expectancy of at least 12 weeks
  • Karnofsky performance status of at least 50
  • No contraindications to MRI scanning with intravenous contrast.
  • MRI scan consistent with brain metastasis as per radiology report.
  • Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
  • Patients must have an extra-cranial primary tumor diagnosis.
  • Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
  • Additional lesions will each be treated with stereotactic radiosurgery.
  • Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
  • 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

Exclusion Criteria:

  • Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
  • Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
  • More than four additional diagnosed brain metastases.
  • Contraindication to general anesthesia.
  • Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
  • Primary brain tumor.
  • Contraindication to MRI scans or intravenous contrast.
  • Pregnant and breast-feeding females.
  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): NCT02514915


Contacts
Contact: Karen Holeva 4126231275 holevakd@upmc.edu

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

Responsible Party: Dwight Heron, Chairman of Clinical Affairs, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02514915     History of Changes
Other Study ID Numbers: 14-150
First Submitted: July 30, 2015
First Posted: August 4, 2015
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Neoplasms