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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
  • - 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.
  • - Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection.
  • - Patient must have a Karnofsky performance score of ≥ 70.

Exclusion Criteria:

  • - Patient deemed medically unfit to undergo surgical resection of brain metastasis.
  • - Prior whole brain radiotherapy.
  • - Patient with contraindication for imaging with MRI.
  • - Inability to participate in study activities due to physical or mental limitations.
  • - Inability or unwillingness to return for all the required follow-up visits.
  • - At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm.
  • - Tumor located in the brainstem.
- Imaging or cytologic evidence of leptomeningeal disease

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01891318
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Case Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Erin Murphy, MD
Principal Investigator Affiliation Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Tumors Metastatic to Brain
Additional Details

PRIMARY OBJECTIVES:

  • I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases.
(Phase I)
  • II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection.
(Phase II) SECONDARY OBJECTIVES:
  • I. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.
  • II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection.
  • III. To determine the rate of radiation necrosis/steroid dependency.
  • IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.
OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study. The following outcomes were removed from the protocol in an amendment:
  • - Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) & Trailmaking Test B, and Trailmaking Test A.
- QOL measured by FACT-BR and EORTC-QLQ30

Arms & Interventions

Arms

Experimental: Treatment (radiosurgery, surgery)

Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.

Interventions

Radiation: - radiosurgery

Undergo radiosurgery

Procedure: - therapeutic conventional surgery

Undergo surgical resection

Procedure: - quality-of-life assessment

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Withdrawn

Address

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106

Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

Site Contact

Erin Murphy, MD

[email protected]

866-223-8100

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