Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02220 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0552 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (pre-operative SRS) | Experimental | Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment. |
|
| Group II (post-operative SRS) | Active Comparator | Patients undergo surgery within 30 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Distant brain control |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Circulating tumor cell analysis |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debra Yeboa | Contact | 713-563-2300 | dnyeboa@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Debra N Yeboa | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40531511 | Derived | Yeboa DN, Li J, Lin R, Prabhu SS, Beckham TH, Woodhouse K, Swanson TA, Weinberg JS, Wang X, Chi X, Ejezie CL, Suki D, Wang C, Ene C, McCutcheon IE, McGovern S, McAleer MF, Tom M, Ghia A, Perni S, Jiang W, De B, Chung C, Kim BYS, O'Brien BJ, Huse JT, Wefel JS, Court L, Tawbi H, Janku F, Guha-Thakurta N, Debnam JM, Johnson J, Taslicay CA, Alvarez-Breckenridge C, Raza SM, Heimberger AB, DeMonte F, North R, Briere TM, de Groot JF, Sawaya R, Grosshans D, Lang FF, Rao G, Ferguson SD. Therapy, Safety, and Logistics of Preoperative vs Postoperative Stereotactic Radiation Therapy: A Preliminary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2025 Aug 1;11(8):890-899. doi: 10.1001/jamaoncol.2025.1770. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2024 | Mar 11, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaire Administration | Other | Ancillary studies |
|
| Stereotactic Radiosurgery | Radiation | Undergo SRS |
|
|
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 |
| 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 |
| Up to 4 years |
| Cerebral spinal fluid analysis | Up to 4 years |
| 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 |
| Symptom burden questionnaire | Measured by the MD Anderson Symptom Inventory Brain Tumor (MDASI-BT). | Up to 1 year from start of treatment |
| 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 |
| Neurocognitive function measured by COWA questionnaire | Measured by neurocognitive decline on Controlled Oral Word Association (COWA) | Up to 1 year from start of treatment |
| 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 |
| 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 |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided