Stereotactic Radiosurgery for the Treatment of Patients With Small Cell Lung Cancer Brain Metastasis

NCT04516070 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2019-0900NCI-2020-05720
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial investigates how stereotactic radiosurgery affects brain functions while treating patients with small cell lung cancer that has spread to the brain (brain metastasis). Standard of care treatment consists of whole brain radiation therapy, which targets the entire brain, and may result in side effects affecting the nervous system. Stereotactic radiosurgery only targets areas of the brain that are suspected to be affected by the disease. The purpose of this trial is to learn if and how patients' brain functions are affected by the use of stereotactic radiosurgery rather than whole brain radiation therapy in managing brain metastasis caused by small cell lung cancer. Stereotactic radiosurgery may help patients avoid nervous system side effects caused by whole brain radiation therapy.

Conditions

Metastatic Malignant Neoplasm in the Brain; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Metastatic Lung Small Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Cognitive decline

  Will be defined as a decline of \>= 1 standard deviation from baseline on at least 1 of the 5 cognitive tests. Will be estimated along with the 95% confidence interval. For patients with or without prior radiation therapy to the central nervous system, the cognitive decline rate will also be estimated respectively. Fisher exact test will be used to compare the neurocognitive decline rate at 3 month post-SRS in subgroups (e.g. prior therapy difference).

  At 3 months post-stereotactic radiosurgery (SRS)

• Incidence of adverse events

  All toxicities will be assessed with National Cancer Institute predefined Common Terminology Criteria for Adverse Events version 5.

  Up to 36 months

Secondary Outcomes (13)

• Cognitive decline

  Up to 36 months

• Change in neurocognitive score

  Baseline, up to 36 months

• Overall survival

  Time from SRS until death or last follow-up, assessed up to 36 months

• Small cell lung cancer (SCLC)-specific survival

  Time from SRS till SCLC-related death or last follow-up, assessed up to 36 months

• Time to neurocognitive decline

  Time from date of SRS till the cognitive decline, assessed up to 36 months

Study Arms (1)

Treatment (SRS)

EXPERIMENTAL

Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion.

Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

Undergo SRS

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Treatment (SRS)

Questionnaire Administration OTHER

Ancillary studies

Treatment (SRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have Eastern Cooperative Oncology Group (ECOG) =\< 3
• All patients must have histologic evidence suggesting small cell lung cancer. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc.). Cytology-alone is not an acceptable method of diagnosis.
• Patient has 10 or less brain metastases on contrast-enhanced brain MRI scan obtained no greater than 6 weeks prior to study registration. Biopsy of brain metastasis is not required. A patient may be enrolled with zero brain metastasis assuming that the SRS is to be directed at the post-operative surgical cavity of a resected metastasis.
• Patients must be eligible to have all lesions treated with stereotactic radiosurgery as determined by the study radiation oncologist
• Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
• Patients should have normal coagulation \[International Normalized Ratio (INR) \< 1.3\]. within 28 days of enrollment.
• Patient's primary language is English
• No prior radiation therapy to the brain, including WBRT, PCI, or SRS
• Performance Status Assessment
• Standard ECOG performance status assessment will be used and determined by the treating physician

You may not qualify if:

• Patients are excluded if they have a history of metastatic cancer in addition to small cell malignancy or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded
• Patients are excluded if there is radiographic evidence of leptomeningeal disease
• Patients are excluded if there are malignant cells identified in the CSF on cytologic examination
• Patients are not excluded for circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the CSF
• Female patients of childbearing age are excluded if they are pregnant as determined with a urine or serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breast-feeding
• Patients are excluded if they are unable to obtain an MRI scan for any other reason, including gadolinium allergy
• Patients are excluded with medical history of a psychiatric or neurologic illness, or other comorbidities believed to affect cognitive function. Subjects with neurocognitive deficit related to brain metastasis are an exception to this criterion and may qualify for the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Brain Neoplasms; Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jing Li

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: August 28, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)