Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neo-Adjuvant vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors

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.
 
ClinicalTrials.gov Identifier: NCT03750227
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm in the Brain Solid Neoplasm Procedure: Conventional Surgery Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Radiosurgery Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neo-Adjuvant vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : November 8, 2025
Estimated Study Completion Date : November 8, 2025

Arm Intervention/treatment
Active Comparator: Arm A (Pre-operative SRS)
Within 2 weeks, patients undergo surgery on day 1.
Procedure: Conventional Surgery
Undergo surgery

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Radiosurgery
Undergo stereotactic radiosurgery
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • stereotactic radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery

Experimental: Arm B (Post-operative SRS)
Within 4 weeks, patients undergo stereostatic radiosurgery on day 1.
Procedure: Conventional Surgery
Undergo surgery

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Radiosurgery
Undergo stereotactic radiosurgery
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • stereotactic radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery




Primary Outcome Measures :
  1. Central nervous system (CNS) composite endpoint event (CNS-CE event) [ Time Frame: Time from study randomization to documentation of the first CNS-CE event, assessed up to 5 years ]
    The CNS-CE event distributions will be estimated using the Kaplan-Meier method.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From start of study therapy to death due to any cause, assessed up to 5 years ]
    The distribution of overall survival for both groups of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.

  2. Incidence of adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 5 years post treatment ]
    The overall adverse event rates for grade 3 or higher adverse events will be compared using Chi-Square or Fisher?s Exact tests between the 2 treatment groups.

  3. CNS-CE event free survival time adjusted for stratification factors [ Time Frame: Up to 5 years ]
    Cox-models will be used that incorporate the stratification factors to test for differences in treatment arms after adjusting for stratification factors listed in section 5.0.

  4. CNS-CE event free rate [ Time Frame: At 6 months ]
    The 6-month CNS-CE rates from the K-M analysis will be compared between the arms.

  5. Patient-reported outcome Quality of Life(QOL): FACT-Br Global Score [ Time Frame: Baseline to 6 months post treatment ]
    QOL will be assessed via changes in the Functional Assessment of Cancer Therapy-Brain (FACT-Br) Global Score. FACT-Br is a 24-item questionnaire where patients rate each item using a five-point scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL.

  6. Rate of completion of therapies [ Time Frame: Up to 5 years post treatment ]
    The rate of completion of planned therapies will be compared using Chi-Square or Fisher?s Exact tests between the 2 treatment groups.

  7. Time to systemic therapy [ Time Frame: Time to initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS, assessed up to 5 years ]
    Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.

  8. Time to regional progression [ Time Frame: Up to 5 years post treatment ]
    Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.

  9. Time central nervous system (CNS) progression [ Time Frame: Up to 5 years post treatment ]
    Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.

  10. Time to subsequent treatment, including whole-brain radiotherapy (WBRT) [ Time Frame: Up to 5 years ]
    Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.

  11. Rate of neurosurgical morbidity [ Time Frame: Up to 5 years post treatment ]
    The rates of surgical morbidity including postoperative complications such as wound infection, need for longer hospital stays, or readmission will be compared using Chi-Square or Fisher?s Exact tests between the 2 treatment groups.



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.


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

Inclusion Criteria:

  • Histological or cytological confirmation of solid tumor malignancy and/or clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings
  • Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate
  • Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=< 10 metastases)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
  • Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
  • Provide written informed consent
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) or agreement to complete pre-specified magnetic resonance imaging (MRI) series and follow-up visits according to the study timeline mailing in digital copies of images as well as clinical notes

Exclusion Criteria:

  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. * NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Prior open neurosurgery for malignancy
  • Primary germ cell tumor, small cell carcinoma, or lymphoma
  • History of whole brain radiation therapy (WBRT)
  • Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants are eligible
  • Leptomeningeal metastasis/disease
  • A brain metastasis that is located =< 5 mm of the optic chiasm
  • Any brain metastasis > 5 cm in size
  • > 10 brain metastases
  • Indication for surgical resection of >= 2 brain metastases
  • Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab

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): NCT03750227


Locations
Layout table for location information
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Daniel Trifiletti         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Elizabeth Yan         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Yan Mayo Clinic

Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03750227    
Other Study ID Numbers: MC167C
NCI-2018-02799 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
17-007708
MC167C ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms