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Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

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ClinicalTrials.gov Identifier: NCT03741673
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain. SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.

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

Detailed Description:

PRIMARY OBJECTIVES:

I. To investigate the 1 year leptomeningeal disease (LMD)-free rate among patients with surgically resectable metastatic brain lesions randomized to post-operative stereotactic radiosurgery (SRS) (standard care) versus pre-operative SRS followed by surgery (experimental arm).

SECONDARY OBJECTIVES:

I. To investigate the local control (LC), distant brain metastasis rate, overall survival (OS) of pre-operative (pre-op) versus (vs) post-operative (post-op) SRS in patients with brain metastasis.

EXPLORATORY OBJECTIVES:

I. To assess the reliability of different imaging features by using a combination of patient data and phantom data to quantify the uncertainties associated with using magnetic resonance imaging (MRI) for radiomics studies.

II. To assess the correlation of imaging-pathology correlates using multiparametric imaging that characterize the tumor and peri-tumoral microenvironment including features such as tumor vascular characteristics, cellular density, oxygenation and presence of inflammation/immune reactivity.

III. To investigate the neuro-cognitive impact, patient reported outcomes and health-related quality of life of pre-operative (pre-op) vs post-operative (post-op) SRS in patients with brain metastasis.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (PRE-OPERATIVE SRS): Patients undergo SRS within 15 days of randomization followed by surgery within 15 days. Patients may undergo additional SRS if disease returns after treatment.

GROUP II (POST-OPERATIVE SRS): Patients undergo surgery within 15 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.

After completion of study treatment, patients are followed up periodically.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : July 10, 2022
Estimated Study Completion Date : July 10, 2022

Arm Intervention/treatment
Experimental: Group I (pre-operative SRS)
Patients undergo SRS within 15 days of randomization followed by surgery within 15 days. Patients may undergo additional SRS if disease returns after treatment.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

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

Active Comparator: Group II (post-operative SRS)
Patients undergo surgery within 15 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Radiosurgery
Undergo SRS
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. Leptomeningeal disease (LMD)-free rate [ Time Frame: At 1 year ]
    Aalen-Johansen estimates will be used for LMD. Uni- and multi-variable analysis of time to LMD will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.


Secondary Outcome Measures :
  1. Local control rate [ Time Frame: At 1 year ]
    Aalen-Johansen estimates will be used for local recurrence. Uni- and multi-variable analysis of time to local recurrence will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.

  2. Distant brain control [ Time Frame: At 1 year ]
    Aalen-Johansen estimates will be used for distant brain recurrence. Uni- and multi-variable analysis of time to distant brain recurrence will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.

  3. Overall survival (OS) [ Time Frame: At 1 year ]
    Kaplan-Meier estimates will be utilized for survival. Uni- and multi-variable analysis of overall survival will be done with Cox proportional hazards regression.


Other Outcome Measures:
  1. Delta radiomics [ Time Frame: Up to 4 years ]
    Radiomic texture features and changes in features at diagnosis with pathology and over time will be included in various classifiers for modeling including decision trees, discriminate analysis, and nearest neighbor classifiers using classification learner in Matlab.

  2. Circulating tumor cell analysis [ Time Frame: Up to 4 years ]
  3. Cerebral spinal fluid analysis [ Time Frame: Up to 4 years ]
  4. Neurocognitive function measured by HVLT-R questionnaire [ Time Frame: Up to 1 year from start of treatment ]
    Measured by neurocognitive decline on Hopkins Verbal Learning Test-Revised (HVLT-R)

  5. Symptom burden [ Time Frame: Up to 1 year from start of treatment ]
    Measured by the MD Anderson Symptom Inventory Brain Tumor (MDASI-BT).

  6. Health outcomes [ Time Frame: Up to 1 year from start of treatment ]
    Measured by the European Quality of Life Five Dimension Five Level Scale questionnaire (EQ-5D-5L).

  7. Neurocognitive function measured by COWA questionnaire [ Time Frame: Up to 1 year from start of treatment ]
    Measured by neurocognitive decline on Controlled Oral Word Association (COWA)

  8. Neurocognitive function measured by TMT questionnaire [ Time Frame: Up to 1 year from start of treatment ]
    Measured by neurocognitive decline on and Trail Making Test (TMT) parts A and B

  9. Neurocognitive function measured by CTB COMP questionnaire [ Time Frame: Up to 1 year from start of treatment ]
    Measured by neurocognitive decline on Clinical Trial Battery Composite (CTB COMP) score.



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:

  • The primary lesion pre-operatively can have a maximum diameter of =< 4 cm for single fraction and =< 7 cm for multifraction therapy
  • Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H&P) or presentation at brain metastasis tumor board conference note
  • Patients must have a Karnofsky performance scores >= 70 or Eastern Cooperative Oncology Group (ECOG) >= 2 within 30 days of enrollment
  • Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form
  • No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review
  • Documented history of malignancy

Exclusion Criteria:

  • Patients who have received prior radiation therapy to the brain for any reason
  • The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma
  • For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)

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): NCT03741673


Contacts
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Contact: Debra Yeboa 713-563-2300 dnyeboa@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Debra N. Yeboa    713-563-2300      
Principal Investigator: Debra N. Yeboa         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Debra N Yeboa M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03741673     History of Changes
Other Study ID Numbers: 2018-0552
NCI-2018-02220 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0552 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Neoplasms
Neoplasms, Second Primary
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases