Status:
ACTIVE_NOT_RECRUITING
Stereotactic Radiosurgery for the Treatment of Patients With Small Cell Lung Cancer Brain Metastasis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Lung Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ex...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04516070
Start Date
August 28 2020
End Date
December 31 2026
Last Update
September 5 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030