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

NCT03391362 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 17-550
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• All-cause mortality

  Until death or loss to follow up, up to 24 months

• Quality of life as assessed by patient Questionnaire

  Until death or loss to follow up, up to 24 months

• Neurocognitive function: Verbal learning and memory

  12 months

• Neurocognitive function: Visual attention and task switching

  12 months

• Neurocognitive function: Verbal fluency

  12 months

Study Arms (1)

Stereotactic Radiation

EXPERIMENTAL

* 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

Interventions

Stereotactic Radiation RADIATION

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

Stereotactic Radiation

Eligibility Criteria

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

You may qualify if:

• 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.
• definitive intracranial lesions must be present on MRI of the brain.
• Age \>=18 years at diagnosis of brain metastases.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Aizer AA, Tanguturi SK, Shi DD, Catalano PJ, Shin KY, Ricca I, Johnson M, Benham G, Kozono DE, Mak RH, Hertan L, Chipidza F, Krishnan M, Pashtan I, Peng L, Qian JM, Shiloh RY, Cagney DN, Sands J, Brown PD, Wen PY, Haas-Kogan DA, Rahman R. Stereotactic Radiosurgery in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Multi-Institutional, Phase II, Prospective Clinical Trial. J Clin Oncol. 2025 Sep 20;43(27):2986-2997. doi: 10.1200/JCO-25-00056. Epub 2025 Jul 11.

  PMID: 40644657 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ayal A Aizer, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 5, 2018
• Study Start: February 23, 2018
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)