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

Primary Purpose

Brain Metastases, Small Cell Lung Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiation
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Small Cell Lung Cancer, Brain Metastases, Brain metastasis, Lung cancer, Stereotactic radiation, Stereotactic radiosurgery, SRS, Stereotactic, Radiation, Quality of life, Neurocognitive, Neurocognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Radiation

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

All-cause mortality
Clinical parameter
Quality of life as assessed by patient Questionnaire
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Neurocognitive function: Verbal learning and memory
Hopkins Verbal Learning Test -Revised (HVLT-R)
Neurocognitive function: Visual attention and task switching
Trail Making Test Part A and B (TMT)
Neurocognitive function: Verbal fluency
Controlled Oral Word Association Test (COWAT)
Neurocognitive function: Cognitive impairment
Mini Mental Status Examination (MMSE)
Ability to complete activities of daily living
Questionnaire - EQ-5D
Performance status
Karnofsky performance status
Incidence and time to detection of new brain metastases
Radiographic assessment of first appearance of new brain metastases
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
Incidence and time to development of radiation necrosis
Radiographic assessment of first appearance of radiation necrosis
Incidence and time to development of leptomeningeal disease
Radiographic assessment of first appearance of leptomeningeal disease
Incidence and time to progressive intracranial disease
Radiographic assessment of first appearance of progressive intracranial disease
Incidence and time to salvage craniotomy
Clinical assessment of first use of neurosurgical resection as salvage therapy
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
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

Full Information

First Posted
December 21, 2017
Last Updated
September 21, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03391362
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayal A Aizer, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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