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Search Results

Stereotactic Radiosurgery for the Treatment of Patients With Small Cell Lung Cancer Brain Metastasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have Eastern Cooperative Oncology Group (ECOG) =< 3.
  • - All patients must have histologic evidence suggesting small cell lung cancer.
Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc.). Cytology-alone is not an acceptable method of diagnosis.
  • - Patient has 10 or less brain metastases on contrast-enhanced brain MRI scan obtained no greater than 6 weeks prior to study registration.
Biopsy of brain metastasis is not required. A patient may be enrolled with zero brain metastasis assuming that the SRS is to be directed at the post-operative surgical cavity of a resected metastasis.
  • - Patients must be eligible to have all lesions treated with stereotactic radiosurgery as determined by the study radiation oncologist.
  • - Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
  • - Patients should have normal coagulation [International Normalized Ratio (INR) < 1.3].
within 28 days of enrollment.
  • - Patient's primary language is English.
  • - No prior radiation therapy to the brain, including WBRT, PCI, or SRS.
  • - Performance Status Assessment.
  • - Standard ECOG performance status assessment will be used and determined by the treating physician.

Exclusion Criteria:

  • - Patients are excluded if they have a history of metastatic cancer in addition to small cell malignancy or a history of uncontrolled non-metastatic cancer.
Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded.
  • - Patients are excluded if there is radiographic evidence of leptomeningeal disease.
  • - Patients are excluded if there are malignant cells identified in the CSF on cytologic examination.
  • - Patients are not excluded for circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the CSF.
  • - Female patients of childbearing age are excluded if they are pregnant as determined with a urine or serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breast-feeding.
  • - Patients are excluded if they are unable to obtain an MRI scan for any other reason, including gadolinium allergy.
  • - Patients are excluded with medical history of a psychiatric or neurologic illness, or other comorbidities believed to affect cognitive function.
Subjects with neurocognitive deficit related to brain metastasis are an exception to this criterion and may qualify for the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04516070
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jing Li
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment (SRS)

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.

Interventions

Other: - Questionnaire Administration

Ancillary studies

Radiation: - Stereotactic Radiosurgery

Undergo SRS

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Nearest Location


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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