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Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-6 Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03391362
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ayal Aizer, 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 1-6 brain metastases.

The intervention involved in this study is:

-Stereotactic (focused, pinpoint) radiation


Condition or disease Intervention/treatment Phase
Brain Metastases Small Cell Lung Cancer Radiation: Stereotactic Radiation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-6 Brain Metastases: A Single Arm, Phase II Trial
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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
Radiation: Stereotactic Radiation
Stereotactic radiation involves using a high dose of radiation that only targets the specific metastases




Primary Outcome Measures :
  1. Death due to progressive neurologic disease [ Time Frame: 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 :
  1. All-cause mortality [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Clinical parameter

  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)

  4. Neurocognitive function: Visual attention and task switching [ Time Frame: 12 months ]
    Trail Making Test Part A and B (TMT)

  5. Neurocognitive function: Verbal fluency [ Time Frame: 12 months ]
    Controlled Oral Word Association Test (COWAT)

  6. Neurocognitive function: Cognitive impairment [ Time Frame: 12 months ]
    Mini Mental Status Examination (MMSE)

  7. Ability to complete activities of daily living [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Questionnaire - EQ-5D

  8. Performance status [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Karnofsky performance status

  9. Incidence and time to detection of new brain metastases [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Radiographic assessment of first appearance of new brain metastases

  10. Incidence and time to local recurrence of existing brain metastases [ Time Frame: 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

  11. Incidence and time to development of radiation necrosis [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Radiographic assessment of first appearance of radiation necrosis

  12. Incidence and time to development of leptomeningeal disease [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Radiographic assessment of first appearance of leptomeningeal disease

  13. Incidence and time to progressive intracranial disease [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Radiographic assessment of first appearance of progressive intracranial disease

  14. Incidence and time to salvage craniotomy [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Clinical assessment of first use of neurosurgical resection as salvage therapy

  15. Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course [ Time Frame: Until death or loss to follow up, up to 24 months ]
    Clinical assessment of first use of salvage brain-directed radiation

  16. Incidence and time to the development of seizures [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 1-6 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391362


Contacts
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Contact: Ayal A Aizer, MD 617-732-7560 aaaizer@partners.org
Contact: Lacey M Wickersham, BA 617-582-8987 lwickersham@bwh.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lacey M Wickersham, B.A    617-582-8987    lwickersham@bwh.harvard.edu   
Principal Investigator: Ayal A Aizer, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Ayal A Aizer, MD Brigham and Women's Hospital

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Responsible Party: Ayal Aizer, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03391362    
Other Study ID Numbers: 17-550
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ayal Aizer, Dana-Farber Cancer Institute:
Brain Metastases
Brain metastasis
Small Cell Lung Cancer
Lung cancer
Stereotactic radiation
Stereotactic radiosurgery
SRS
Stereotactic
Radiation
Quality of life
Neurocognitive
Neurocognition
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Lung Neoplasms
Neoplasms, Second Primary
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Central Nervous System Diseases
Nervous System Diseases