Trial ID:NCT03391362
Protocol #:17-550
Condition(s):Brain Metastases, Small Cell Lung Cancer
Phase:II
Principal Investigator:Aizer, Ayal
Site Investigator(s):Hertan, Lauren,
Phillips, John,
Site Research Nurse(s):Mann, Eileen, Marie
Roper, Kristin,
Spicer, Beverly, A.
Trial Description:
This research study is studying stereotactic radiation (focused/pinpoint radiation that
targets each individual tumor but not the surrounding brain) instead of whole-brain radiation
(radiation targeting the entire brain) as a possible treatment for patients with small cell
lung cancer and 1-10 brain metastases.
The intervention involved in this study is:
-Stereotactic (focused, pinpoint) radiation
Eligibility Requirements:
- Participants must have a biopsy-proven tumor consistent with small cell lung cancer
and intracranial lesions radiographically consistent with or pathologically proven to
be brain metastases. Patients who have undergone prior systemic therapy are eligible.
Patients who have undergone resection of one or more brain metastases but who have not
yet started adjuvant radiotherapy are eligible for the study.
- 1-10 definitive intracranial lesions must be present on MRI of the brain.
- Age >=18 years at diagnosis of brain metastases.
Exclusion Criteria:
- Participants who have undergone prior radiation for brain metastases.
- Participants who have received prophylactic cranial radiation for prevention of brain
metastases
- Participants who cannot receive gadolinium
- Participants with stage IV-V chronic kidney disease or end stage renal disease
- Participants with widespread, definitive leptomeningeal disease
- Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
- Participants with >6 definitive lesions consistent with brain metastases
- Participants with inadequate mental capacity to complete quality of life
questionnaires
Protocol #: 17-550