Clinical trial NCT03391362: Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases
Official title: Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Single Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Metastases
Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
Brain Metastases
Brain metastasis
Lung cancer
Stereotactic radiation
Stereotactic radiosurgery
SRS
Stereotactic
Radiation
Quality of life
Neurocognitive
Neurocognition
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed 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.

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

Primary outcomes:
measure: Death due to progressive neurologic disease
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: Until death or loss to follow up, up to 24 months
measure: Quality of life as assessed by patient Questionnaire
timeFrame: Until death or loss to follow up, up to 24 months
measure: Neurocognitive function: Verbal learning and memory
timeFrame: 12 months
measure: Neurocognitive function: Visual attention and task switching
timeFrame: 12 months
measure: Neurocognitive function: Verbal fluency
timeFrame: 12 months
measure: Neurocognitive function: Cognitive impairment
timeFrame: 12 months
measure: Ability to complete activities of daily living
timeFrame: Until death or loss to follow up, up to 24 months
measure: Performance status
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to detection of new brain metastases
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to local recurrence of existing brain metastases
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to development of radiation necrosis
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to development of leptomeningeal disease
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to progressive intracranial disease
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to salvage craniotomy
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course
timeFrame: Until death or loss to follow up, up to 24 months
measure: Incidence and time to the development of seizures
timeFrame: Until death or loss to follow up, up to 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Ayal A Aizer, MD
role: PRINCIPAL_INVESTIGATOR
References: