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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 29, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen Shiao, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Neoadjuvant stereotactic radiosurgery Procedure: Neurosurgical resection Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
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.
Radiation: Neoadjuvant stereotactic radiosurgery
Dose escalation of neoadjuvant stereotactic radiosurgery

Procedure: Neurosurgical resection
Surgical resection of newly diagnosed brain metastases
Other Name: craniotomy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Describe preliminary rates of image-complete resection [ Time Frame: 3 years ]
  3. Describe preliminary rates of local tumor control [ Time Frame: 3 years ]
  4. Describe preliminary rates of intracranial control [ Time Frame: 3 years ]
  5. Describe preliminary rates of progression-free survival [ Time Frame: 3 years ]
  6. Describe preliminary rates of leptomeningeal spread [ Time Frame: 3 years ]
  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03163368


Contacts
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Contact: Cynthia Martin 310-423-2276 Cynthia.Martin@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Cynthia Martin    310-423-2276    Cynthia.Martin@cshs.org   
Principal Investigator: Stephen Shiao, MD         
Sub-Investigator: Emi Yoshida, MD         
Sub-Investigator: Amin Mirhadi, MD         
Sub-Investigator: Behrooz Hakimian, MD         
Sub-Investigator: Michele Burnison, MD         
Sub-Investigator: Zachary Zumsteg, MD         
Sub-Investigator: Howard Sandler, MD         
Sub-Investigator: Keith Black, MD         
Sub-Investigator: Ray Chu, MD         
Sub-Investigator: Adam Mamelak, MD         
Sub-Investigator: Chirag Patil, MD         
Sub-Investigator: John Yu, MD         
Sub-Investigator: Jethro Hu, MD         
Sub-Investigator: Jeremy Rudnick, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Stephen Shiao, MD, PhD Cedars-Sinai Medical Center

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Responsible Party: Stephen Shiao, Principal Investigator; Basic Science Director, Radiation Oncology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03163368     History of Changes
Other Study ID Numbers: IIT2016-18-Shiao-NeoAdSRS
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Stephen Shiao, Cedars-Sinai Medical Center:
metastatic tumor
brain lesion
stereotactic radiosurgery
neoadjuvant
maximum tolerated dose
dose escalation
neurosurgical resection
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases