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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03741673
Other study ID # 2018-0552
Secondary ID NCI-2018-0222020
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 8, 2018
Est. completion date July 10, 2024

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Debra Yeboa
Phone 713-563-2300
Email dnyeboa@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (brain metastases). 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.


Description:

PRIMARY OBJECTIVE: 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 OBJECTIVE: 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date July 10, 2024
Est. primary completion date July 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radiation:
Stereotactic Radiosurgery
Undergo SRS

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Delta radiomics 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. Up to 4 years
Other Circulating tumor cell analysis Up to 4 years
Other Cerebral spinal fluid analysis Up to 4 years
Other Neurocognitive function measured by HVLT-R questionnaire Measured by neurocognitive decline on Hopkins Verbal Learning Test-Revised (HVLT-R) Up to 1 year from start of treatment
Other Symptom burden questionnaire Measured by the MD Anderson Symptom Inventory Brain Tumor (MDASI-BT). Up to 1 year from start of treatment
Other Health outcomes questionnaire Measured by the European Quality of Life Five Dimension Five Level Scale questionnaire (EQ-5D-5L). Up to 1 year from start of treatment
Other Neurocognitive function measured by COWA questionnaire Measured by neurocognitive decline on Controlled Oral Word Association (COWA) Up to 1 year from start of treatment
Other Neurocognitive function measured by TMT questionnaire Measured by neurocognitive decline on and Trail Making Test (TMT) parts A and B Up to 1 year from start of treatment
Other Neurocognitive function measured by CTB COMP questionnaire Measured by neurocognitive decline on Clinical Trial Battery Composite (CTB COMP) score. Up to 1 year from start of treatment
Primary Leptomeningeal disease (LMD)-free rate 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. At 1 year
Secondary Local control rate 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. At 1 year
Secondary Distant brain control 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. At 1 year
Secondary Overall survival (OS) Kaplan-Meier estimates will be utilized for survival. Uni- and multi-variable analysis of overall survival will be done with Cox proportional hazards regression. At 1 year
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