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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Cancer; Brain Metastases
• Intervention / Treatment: Radiation: Stereotactic 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Clinical parameter	Until death or loss to follow up, up to 24 months
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
Neurocognitive function: Verbal learning and memory	Hopkins Verbal Learning Test -Revised (HVLT-R)	12 months
Neurocognitive function: Visual attention and task switching	Trail Making Test Part A and B (TMT)	12 months
Neurocognitive function: Verbal fluency	Controlled Oral Word Association Test (COWAT)	12 months
Neurocognitive function: Cognitive impairment	Mini Mental Status Examination (MMSE)	12 months
Ability to complete activities of daily living	Questionnaire - EQ-5D	Until death or loss to follow up, up to 24 months
Performance status	Karnofsky performance status	Until death or loss to follow up, up to 24 months
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Ayal A Aizer, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Lung cancer; Neurocognitive; Stereotactic; Brain Metastases; Small Cell Lung Cancer; SRS; Radiation; Neurocognition; Stereotactic radiosurgery; Brain metastasis; Stereotactic radiation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Nervous System Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Central Nervous System Neoplasms; Neoplasms, Second Primary; Lung Neoplasms; Neoplasm Metastasis; Small Cell Lung Carcinoma; Brain Neoplasms
• Other Study ID Numbers: 17-550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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