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NCT Number: NCT03391362

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Radiation

Radiation

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

Primary outcomes

  1. Neurologic Mortality

    Time frame: 12 months

    Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic progressive disease).

Secondary outcomes

  1. All-cause Mortality

    Time frame: Until death or loss to follow up, up to 24 months

    Death from any cause cumulative incidence estimate assessed at 1 year and 2 year

  2. Quality of Life as Assessed by Patient Questionnaire

    Time frame: Until death or loss to follow up, up to 24 months

    Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

  3. Neurocognitive Function: Verbal Learning and Memory

    Time frame: 12 months

    Hopkins Verbal Learning Test -Revised (HVLT-R). Scores are transformed into Z scores.

  4. Neurocognitive Function: Visual Attention and Task Switching

    Time frame: 12 months

    Trail Making Test Part A and B (TMT). Scores are transformed into Z scores.

  5. Neurocognitive Function: Verbal Fluency

    Time frame: 12 months

    Controlled Oral Word Association Test (COWAT). Scores are transformed into Z scores.

  6. Neurocognitive Function: Cognitive Impairment

    Time frame: 12 months

    Mini Mental Status Examination (MMSE). Scored 0 to 30. Higher scores indicate better cognitive function

  7. Ability to Complete Activities of Daily Living

    Time frame: Until death or loss to follow up, up to 24 months

    Questionnaire - EQ-5D. A patient reported quality of life questionnaire

  8. Performance Status

    Time frame: Until death or loss to follow up, up to 24 months

    Karnofsky performance status. Scale ranges from 0 to 100, with higher scores indicating better function.

  9. One and Two Year Incidence of New Brain Metastases

    Time frame: Until death or loss to follow up, up to 24 months

    1 and 2 year estimates of first appearance of new brain metastases (on radiographic assessment)

  10. Incidence of Existing Brain Metastases

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient radiographic assessment of first event of local recurrence in the brain metastases treated with radiation on trial. One- and 2-Year estimates.

  11. Incidence of Development of Radiographic Radiation Necrosis

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient radiographic assessment of first event of radiation necrosis in the brain metastases treated with radiation on trial. One- and 2-Year cumulative incidence estimates.

  12. Incidence of Development of Leptomeningeal Disease

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient radiographic assessment of first event of leptomeningeal disease. One- and 2-Year estimates.

  13. Incidence of Salvage Craniotomy

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient clinical assessment of first use of neurosurgical resection / craniotomy as salvage therapy in metastases treated with radiation on trial. One- and 2-Year estimates.

  14. Incidence of Additional CNS-directed Radiotherapeutic Treatments (Stereotactic Radiation) After the Initial Course

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient clinical assessment of first use of salvage brain-directed stereotactic radiation. 1- and 2-Year estimates.

  15. Incidence of Seizures

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review. 1 and 2-Year estimates.

  16. Incidence of Symptomatic Radiation Necrosis

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient assessment of first event of symptomatic radiation necrosis in the brain metastases treated with radiation on trial. 1- and 2-Year estimates.

  17. Incidence of Neurologic Death at 2 Years

    Time frame: 2-years

    Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic progressive disease).

  18. Incidence of Additional CNS-directed Radiotherapeutic Treatments (Whole Brain Radiation) After the Initial Course

    Time frame: Until death or loss to follow up, up to 24 months

    Per patient clinical assessment of first use of salvage whole brain radiation. One- and 2-Year estimates.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Dana-Farber Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2027
First posted
Jan 5, 2018
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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