Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-6 Brain Metastases



Status:Recruiting
Conditions:Lung Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/26/2018
Start Date:February 23, 2018
End Date:June 30, 2025
Contact:Ayal A Aizer, MD
Email:aaaizer@partners.org
Phone:617-732-7560

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Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-6 Brain Metastases: A Single Arm, Phase II Trial

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 1-6 brain metastases.

The intervention involved in this study is:

-Stereotactic (focused, pinpoint) radiation

This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of an investigational treatment, in this case stereotactic radiation, to
learn whether this treatment works in treating a specific disease. "Investigational" means
that the treatment is being studied.

In patients with a limited number of brain metastases (spread of a cancer that started
outside of the brain to the brain itself) the standard radiation option is stereotactic
radiation, which involves using a high dose of radiation that only targets the specific
metastases that are visible on imaging of the brain, not the whole brain itself. However,
studies evaluating the role of stereotactic radiation to treat brain metastases generally
excluded patients with small cell lung cancer. Therefore, among patients with small cell lung
cancer and brain metastases, the typical treatment that has been offered is whole brain
radiation. However, whole brain radiation has deleterious associated side effects including
significant fatigue and permanent memory/attention problems. The investigators are studying
whether stereotactic radiation can be effectively utilized for patients with small cell lung
cancer and brain metastases in order to avoid such side effects.

Inclusion Criteria:

- 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.

- 1-6 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
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site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Ayal A Aizer, MD
Phone: 617-525-7984
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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