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

This study is currently recruiting participants.
Verified March 2017 by Case Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01891318
First Posted: July 3, 2013
Last Update Posted: March 29, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  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.

Condition Intervention
Tumors Metastatic to Brain Radiation: radiosurgery Procedure: therapeutic conventional surgery Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I) [ Time Frame: Day 0 ]
  • Local control of brain metastases (Phase II) [ Time Frame: Up to 12 months ]
    The Kaplan-Meier method will be used.


Secondary Outcome Measures:
  • Rate of distant brain failure [ Time Frame: Up to 12 months ]
    The Kaplan-Meier method will be used.

  • Rate of radiation necrosis/steroid dependency [ Time Frame: Up to 12 months ]
  • Rate of salvage treatment [ Time Frame: Up to 12 months ]
    Number of patients that have any salvage treatment, including surgery, SRS, or WBRT.

  • 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 [ Time Frame: Up to 12 months ]
    Methods such as Fisher's exact test, chi-square tests, t-tests or their non-parametric counterparts, the logrank test, and repeated measures analysis of variance (ANOVA) will be used.

  • Quality of life as assessed using Functional Assessment of Cancer Therapy-Brain (FACT-BR) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)30 [ Time Frame: Up to 12 months ]
    Methods such as Fisher's exact test, chi-square tests, t-tests or their non-parametric counterparts, the logrank test, and repeated measures ANOVA will be used.


Estimated Enrollment: 36
Study Start Date: July 2013
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (radiosurgery, surgery)
Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
Radiation: radiosurgery
Undergo radiosurgery
Other Name: radiation surgery
Procedure: therapeutic conventional surgery
Undergo surgical resection
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

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 patients treated with neoadjuvant radiosurgery followed by surgical resection.

III. To estimate neurocognitive outcomes for patients treated with neoadjuvant radiosurgery followed by surgical resection.

IV. To determine the rate of radiation necrosis/steroid dependency. V. To estimate quality of life for patients treated with neoadjuvant radiosurgery followed by surgical resection.

VI. 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.

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

After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months.

  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:

  • 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
  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): NCT01891318


Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Withdrawn
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Erin Murphy, MD    216-445-4895    murphye3@ccf.org   
Principal Investigator: Erin Murphy, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Erin Murphy, MD Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01891318     History of Changes
Other Study ID Numbers: CASE7312
NCI-2013-00644 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 26, 2013
First Posted: July 3, 2013
Last Update Posted: March 29, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No