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

Small Cell Lung Cancer Clinical Trial

Official title:

Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Single Arm, Phase II Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03391362
• Other study ID #: 17-550
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: February 1, 2026

Study information

• Verified date: September 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• Stereotactic Radiation
Stereotactic radiation involves using a high dose of radiation that only targets the specific metastases

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death due to progressive neurologic disease	Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)	12 months
Secondary	All-cause mortality	Clinical parameter	Until death or loss to follow up, up to 24 months
Secondary	Quality of life as assessed by patient Questionnaire	Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)	Until death or loss to follow up, up to 24 months
Secondary	Neurocognitive function: Verbal learning and memory	Hopkins Verbal Learning Test -Revised (HVLT-R)	12 months
Secondary	Neurocognitive function: Visual attention and task switching	Trail Making Test Part A and B (TMT)	12 months
Secondary	Neurocognitive function: Verbal fluency	Controlled Oral Word Association Test (COWAT)	12 months
Secondary	Neurocognitive function: Cognitive impairment	Mini Mental Status Examination (MMSE)	12 months
Secondary	Ability to complete activities of daily living	Questionnaire - EQ-5D	Until death or loss to follow up, up to 24 months
Secondary	Performance status	Karnofsky performance status	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to detection of new brain metastases	Radiographic assessment of first appearance of new brain metastases	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to local recurrence of existing brain metastases	Radiographic assessment of first local recurrence in the 1-6 brain metastases that were initially treated with radiation	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to development of radiation necrosis	Radiographic assessment of first appearance of radiation necrosis	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to development of leptomeningeal disease	Radiographic assessment of first appearance of leptomeningeal disease	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to progressive intracranial disease	Radiographic assessment of first appearance of progressive intracranial disease	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to salvage craniotomy	Clinical assessment of first use of neurosurgical resection as salvage therapy	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course	Clinical assessment of first use of salvage brain-directed radiation	Until death or loss to follow up, up to 24 months
Secondary	Incidence and time to the development of seizures	Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review	Until death or loss to follow up, up to 24 months