Lung Cancer Clinical Trial

Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases

Summary

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

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.
1-10 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

Study is for people with:

Lung Cancer

Estimated Enrollment:

100

Study ID:

NCT03391362

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Lacey M Wickersham, B.A
Contact
617-582-8987
[email protected]
Ayal A Aizer, MD
Principal Investigator

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Study is for people with:

Lung Cancer

Estimated Enrollment:

100

Study ID:

NCT03391362

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

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