Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases
- Conditions
- Brain MetastasesSmall Cell Lung Cancer
- Interventions
- Radiation: Stereotactic Radiation
- Registration Number
- NCT03391362
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic Radiation Stereotactic Radiation * Stereotactic radiation will begin within 14 days of the MRI used for radiation planning * Lesions \<2 cm in maximum diameter will be treated with stereotactic radiosurgery, generally 20 Gy in 1 fraction * Lesions between 2.0 and 3.0 cm in maximum diameter will generally be treated to 18 Gy in 1 fraction * Lesions \>3 cm will be generally be treated with stereotactic radiotherapy to 30 Gy in 5 fractions
- Primary Outcome Measures
Name Time Method Death due to progressive neurologic disease 12 months Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)
- Secondary Outcome Measures
Name Time Method Incidence and time to detection of new brain metastases Until death or loss to follow up, up to 24 months Radiographic assessment of first appearance of new brain metastases
Performance status Until death or loss to follow up, up to 24 months Karnofsky performance status
All-cause mortality Until death or loss to follow up, up to 24 months Clinical parameter
Neurocognitive function: Verbal fluency 12 months Controlled Oral Word Association Test (COWAT)
Incidence and time to salvage craniotomy Until death or loss to follow up, up to 24 months Clinical assessment of first use of neurosurgical resection as salvage therapy
Incidence and time to local recurrence of existing brain metastases Until death or loss to follow up, up to 24 months Radiographic assessment of first local recurrence in the 1-6 brain metastases that were initially treated with radiation
Quality of life as assessed by patient Questionnaire Until death or loss to follow up, up to 24 months Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Neurocognitive function: Visual attention and task switching 12 months Trail Making Test Part A and B (TMT)
Incidence and time to development of radiation necrosis Until death or loss to follow up, up to 24 months Radiographic assessment of first appearance of radiation necrosis
Incidence and time to progressive intracranial disease Until death or loss to follow up, up to 24 months Radiographic assessment of first appearance of progressive intracranial disease
Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course Until death or loss to follow up, up to 24 months Clinical assessment of first use of salvage brain-directed radiation
Incidence and time to the development of seizures Until death or loss to follow up, up to 24 months Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review
Neurocognitive function: Verbal learning and memory 12 months Hopkins Verbal Learning Test -Revised (HVLT-R)
Neurocognitive function: Cognitive impairment 12 months Mini Mental Status Examination (MMSE)
Ability to complete activities of daily living Until death or loss to follow up, up to 24 months Questionnaire - EQ-5D
Incidence and time to development of leptomeningeal disease Until death or loss to follow up, up to 24 months Radiographic assessment of first appearance of leptomeningeal disease
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States