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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05720 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0900 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial investigates how stereotactic radiosurgery affects brain functions while treating patients with small cell lung cancer that has spread to the brain (brain metastasis). Standard of care treatment consists of whole brain radiation therapy, which targets the entire brain, and may result in side effects affecting the nervous system. Stereotactic radiosurgery only targets areas of the brain that are suspected to be affected by the disease. The purpose of this trial is to learn if and how patients' brain functions are affected by the use of stereotactic radiosurgery rather than whole brain radiation therapy in managing brain metastasis caused by small cell lung cancer. Stereotactic radiosurgery may help patients avoid nervous system side effects caused by whole brain radiation therapy.
PRIMARY OBJECTIVE:
I. To estimate the cognitive decline rate at 3 months.
SECONDARY OBJECTIVES:
I. To examine cognitive decline rate on each individual cognitive test at each time point.
II. To examine cognitive decline rates using reliable change index methodology. III. To report the overall survival of patients (death due to any cause) of patients receiving stereotactic radiosurgery (SRS) for small cell lung cancer (SCLC) brain metastasis.
IV. To report rates of local tumor control (of the treated lesions) in the brain post-treatment, as dictated by magnetic resonance imaging (MRI) surveillance schedule above.
V. To report distant tumor control in the brain (of non-treated lesions) post-treatment, as dictated by MRI surveillance schedule above.
VI. To report time elapsed from SRS to whole brain radiation therapy (WBRT). VII. To report rate of intracranial toxicity of SRS in the setting of prior WBRT.
VIII. To report rates of intracranial toxicity of concurrent atezolizumab with SRS.
IX. To determine rates of systemic and intracranial disease control (time to progression) in those who are treated concurrently with atezolizumab and SRS.
X. To determine the rates of SCLC-specific survival. XI. To assess the pre-treatment factors and baseline characteristics in the predictive determination of local control, intracranial control, systemic control, and neurocognitive outcomes.
XII. To assess the correlation between number of lesions and total volume of intracranial disease and neurocognitive outcome.
XIII. To document post-treatment intracranial toxicity profile in patients after SRS.
CORRELATIVE OBJECTIVE:
I. Cerebral spinal fluid (CSF) biomarkers.
OUTLINE:
Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 16, 20, 24, 30, and 36 months after SRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (SRS) | Experimental | Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive decline | Will be defined as a decline of >= 1 standard deviation from baseline on at least 1 of the 5 cognitive tests. Will be estimated along with the 95% confidence interval. For patients with or without prior radiation therapy to the central nervous system, the cognitive decline rate will also be estimated respectively. Fisher exact test will be used to compare the neurocognitive decline rate at 3 month post-SRS in subgroups (e.g. prior therapy difference). | At 3 months post-stereotactic radiosurgery (SRS) |
| Incidence of adverse events | All toxicities will be assessed with National Cancer Institute predefined Common Terminology Criteria for Adverse Events version 5. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive decline | Will use descriptive statistics and boxplots to summarize and illustrate the neurocognitive function score at each assessment time. | Up to 36 months |
| Change in neurocognitive score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Li | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2023 | Oct 24, 2024 |
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| Stereotactic Radiosurgery |
| Radiation |
Undergo SRS |
|
|
Will summarize and illustrate the change from baseline in neurocognitive score. Will also model the cognitive data with mixed effects regression including baseline neurocognitive scores, time, and number of lesions, extra-cranial disease, and a patient specific random effect.
| Baseline, up to 36 months |
| Overall survival | Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors. | Time from SRS until death or last follow-up, assessed up to 36 months |
| Small cell lung cancer (SCLC)-specific survival | Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors. | Time from SRS till SCLC-related death or last follow-up, assessed up to 36 months |
| Time to neurocognitive decline | Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors. | Time from date of SRS till the cognitive decline, assessed up to 36 months |
| Time duration from SRS to whole brain radiation therapy (WBRT) | Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors. | Time from SRS to the start of WBRT treatment, assessed up to 36 months |
| Local tumor control rates | Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate. | Up to 36 months |
| Distant tumor control rate | Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate. | Up to 36 months |
| Rate of systemic and intracranial disease control rate | Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate. | Up to 36 months |
| Response to SRS therapy | Will be determined by the radiology report. Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate. | Up to 36 months |
| Post-treatment intracranial toxicity profile | Will be summarized and documented. | Up to 36 months |
| Rate of intracranial toxicity of SRS in the setting of prior WBRT | Will be summarized according to intensity and treatment relationship, and categorized by System Organ Class. | Up to 36 months |
| Rate of intracranial toxicity concurrent atezolizumab with SRS | Will be summarized according to intensity and treatment relationship, and categorized by System Organ Class. | Up to 36 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D001932 | Brain Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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