RECRUITING

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

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Conditions

Tumors Metastatic to Brain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Official Title

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Quick Facts

Study Start:2013-07-03
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01891318

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
  2. * Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
  3. * Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
  4. * Patient must have a Karnofsky performance score of ≥ 70
  1. * Patient deemed medically unfit to undergo surgical resection of brain metastasis
  2. * Prior whole brain radiotherapy
  3. * Patient with contraindication for imaging with MRI
  4. * Inability to participate in study activities due to physical or mental limitations
  5. * Inability or unwillingness to return for all the required follow-up visits
  6. * At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
  7. * Tumor located in the brainstem
  8. * Imaging or cytologic evidence of leptomeningeal disease

Contacts and Locations

Study Contact

Erin Murphy, MD
CONTACT
1-866-223-8100
TaussigResearch@ccf.org

Principal Investigator

Erin Murphy, MD
PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Erin Murphy, MD, PRINCIPAL_INVESTIGATOR, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-07-03
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2013-07-03
Study Completion Date2024-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Tumors Metastatic to Brain