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Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors

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ClinicalTrials.gov Identifier: NCT03163368
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Stephen Shiao, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE May 19, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date July 23, 2021
Actual Study Start Date  ICMJE May 9, 2017
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
Maximum tolerated dose (MTD) [ Time Frame: 1 month after neurosurgery ]
To determine the maximum tolerated dose of radiosurgery given prior to neurosurgery in subjects with brain metastases of up to 4 cm.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • Adverse events [ Time Frame: 1 month after neurosurgery ]
    To describe the adverse events associated with radiosurgery when administered prior to neurosurgical resection of brain metastases.
  • Describe preliminary rates of image-complete resection [ Time Frame: 3 years ]
  • Describe preliminary rates of local tumor control [ Time Frame: 3 years ]
  • Describe preliminary rates of intracranial control [ Time Frame: 3 years ]
  • Describe preliminary rates of progression-free survival [ Time Frame: 3 years ]
  • Describe preliminary rates of leptomeningeal spread [ Time Frame: 3 years ]
  • Describe preliminary rates of rate of salvage treatment [ Time Frame: 3 years ]
    Salvage treatment is any additional local treatment (surgery or radiation) in the setting of recurrent or progressive disease after the current treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors
Official Title  ICMJE A Phase 1 Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors
Brief Summary The purpose of this study is to study if giving radiation to a brain tumor (a procedure called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep brain tissue healthy, while possibly eliminating the need to return for radiation once a patient has healed from neurosurgery. This study will also seek the best radiation dose on a brain tumor based on how well the radiation therapy works and asses the side-effects.
Detailed Description

Radiosurgery is a non-surgical radiation therapy that can deliver targeted radiation to small brain tumors. Radiosurgery is considered to be part of standard of care. Typically for standard of care, radiosurgery is given after a patient has healed from neurosurgery, in an attempt to destroy any cancer cells that may be left after surgery. Patients who agree to participate in this research study will receive radiosurgery before their neurosurgery.

The timing of radiosurgery (pre-operatively) and the dosing to determine the safest dose is considered experimental.

By giving radiation the typical way, after surgery, a larger area of the brain must be covered, which means healthy brain tissue also receives radiation, whereas radiation before surgery will specifically target the tumor.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE
  • Radiation: Neoadjuvant stereotactic radiosurgery
    Dose escalation of neoadjuvant stereotactic radiosurgery
  • Procedure: Neurosurgical resection
    Surgical resection of newly diagnosed brain metastases
    Other Name: craniotomy
Study Arms  ICMJE Experimental: Neoadjuvant stereotactic radiosurgery
Stereotactic radiosurgery will be performed prior to neurosurgical resection of the indexed brain metastasis. The dose of radiation to be administered to the indexed lesion will be established as a function of tumor size.
Interventions:
  • Radiation: Neoadjuvant stereotactic radiosurgery
  • Procedure: Neurosurgical resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
  • MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
  • MR evidence of at least one brain lesion ≤ 40 mm in maximal diameter that is deemed to be surgically resectable as evaluated by the neurosurgeon and appropriate for SRS. All other brain lesions must be appropriate for SRS alone and treated according to physician preference. Prior neurosurgery and/or prior SRS at a non-overlapping location are permitted at the discretion of the treating physician.
  • Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
  • Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
  • Patients aged ≥ 18 years.
  • Life expectancy ≥ 3 months
  • Non-acute KPS ≥ 60%

Exclusion Criteria:

  • Patients deemed medically unfit to undergo surgical resection of brain metastasis, such as those who are neurologically or hemodynamically unstable despite appropriate medical interventions.
  • Patients who have had whole brain radiation within the previous three months.
  • Patients with >4 brain metastases.
  • Active or prior: documented inherited hypersensitivity syndromes, certain autoimmune diseases, and certain collagen vascular diseases. For example, any radiation hypersensitivity syndrome, including, but not limited to, ataxia-telangiectasia, Gorlin syndrome, multiple sclerosis, scleroderma, and systemic lupus erythematosus.
  • Radiographic or cytologic evidence of leptomeningeal disease.
  • Patients receiving methotrexate, adriamycin, epirubicine, or navelbin for one week prior to or concurrently with SRS. Note: All other systemic anti-cancer therapies will be reviewed on a case-by-case basis by study PI to determine if appropriate for study treatment and documented within the research record or EMR.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cynthia Martin 310-423-2276 Cynthia.Martin@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03163368
Other Study ID Numbers  ICMJE IIT2016-18-Shiao-NeoAdSRS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stephen Shiao, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Shiao, MD, PhD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP