Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for English-speaking patients with small cell lung cancer that has spread to the brain, who have not had prior brain radiation therapy. They must be physically able to participate (ECOG <=3), have 10 or fewer brain metastases, and no history of psychiatric/neurologic illness affecting cognition. Pregnant or breastfeeding women are excluded.Inclusion Criteria
My diagnosis of small cell lung cancer is confirmed through tissue samples.
I can take care of myself but may not be able to do heavy physical work.
I have not had radiation therapy to my brain.
Exclusion Criteria
I am not pregnant or breastfeeding.
Treatment Details
The trial studies stereotactic radiosurgery's effect on brain function in treating brain metastasis from small cell lung cancer. It compares this targeted approach to standard whole-brain radiation therapy, aiming to reduce nervous system side effects.
1Treatment groups
Experimental Treatment
Group I: Treatment (SRS)Experimental Treatment2 Interventions
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.
Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
πͺπΊ Approved in European Union as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
πΊπΈ Approved in United States as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
- Liver tumors
- Lung tumors
- Spinal cord tumors
π¨π¦ Approved in Canada as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
π―π΅ Approved in Japan as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
π¨π³ Approved in China as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
π¨π Approved in Switzerland as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Loading ...
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator