Stereotactic Radiosurgery in Treating Patients with Small Cell Cancer and 1-6 Brain Metastases

Status: Active

Description

This phase II trial studies how well stereotactic radiosurgery works in treating patients with small cell cancer and 1-6 tumors that have spread to the brain from other parts of the body. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Eligibility Criteria

Inclusion Criteria

  • Participants must have a biopsy-proven tumor consistent with small cell lung cancer, or small cell cancer of any primary site, and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases; patients who have undergone prior systemic therapy are eligible
  • 1-6 definitive intracranial lesions must be present on magnetic resonance imaging (MRI) of the brain

Exclusion Criteria

  • Participants who have undergone prior radiation for brain metastases; patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study
  • 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. Lesions 2 mm in maximum unidimensional size or less may not be included in the total count if not definitive at the discretion of the radiation oncologist
  • Participants with inadequate mental capacity to complete quality of life questionnaires

Locations & Contacts

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: Lauren M. Hertan
Phone: 617-667-2345
Email: lhertan@bidmc.harvard.edu
Brigham and Women's Hospital
Status: Active
Contact: Ayal Aaron Aizer
Phone: 617-732-7560
Email: aaaizer@partners.org
Dana-Farber Cancer Institute
Status: Active
Contact: Ayal Aaron Aizer
Phone: 617-732-7560
Email: aaaizer@partners.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To test the hypothesis that, among patients with small cell lung cancer (SCLC) or small cell cancer of any primary and 1-6 brain metastases, use of stereotactic radiation will not result in a worse rate of neurologic death than historical controls managed with whole-brain radiation therapy (WBRT).

SECONDARY OBJECTIVES:

I. All-cause mortality.

II. Quality of life.

III. Neurocognitive function.

IV. Ability to complete activities of daily living.

V. Performance status.

VI. Incidence and time to detection of new brain metastases.

VII. Incidence and time to local recurrence of existing brain metastases.

VIII. Incidence and time to development of radiation necrosis.

IX. Incidence and time to development of leptomeningeal disease.

X. Incidence and time to progressive intracranial disease.

XI. Incidence and time to salvage craniotomy.

XII. Incidence and time to additional central nervous system (CNS)-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course.

XIII. Incidence and time to the development of seizures.

OUTLINE:

Patients with lesions < 3 cm in maximum diameter undergo 1 fraction of stereotactic radiosurgery over 30-60 minutes, and participants with lesions > 3 cm in maximum diameter undergo stereotactic radiosurgery over 30-60 minutes once daily on days 1-5 for 5 fractions.

After completion of study treatment, patients are followed up every 2-3 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Ayal Aaron Aizer

Trial IDs

Primary ID 17-550
Secondary IDs NCI-2018-00391
Clinicaltrials.gov ID NCT03391362