RECRUITING

Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (VMAT), works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.

Official Title

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

Quick Facts

Study Start:2025-02-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06518057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and/or through CSF cytology
  2. * Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
  3. * Patients ≥ 18 years old
  4. * Karnofsky performance status (KPS) ≥ 60
  5. * The patient is able to provide informed consent
  6. * Hemoglobin \> 8 g/dL
  7. * Absolute neutrophil count \> 1,000/mm
  8. * Platelet count \> 100,000/mm
  9. * Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \[≥ 60 years old, or with no menses for \> 1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment
  10. * Patients with reproductive potential must agree to practice an effective contraceptive method
  1. * Patients with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
  2. * Patients with extensive systemic disease and without reasonable systemic treatment options
  3. * Patients who are unable to undergo MRI brain and spine with gadolinium contrast
  4. * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
  5. * Gross ventricular disease
  6. * Brain metastases within 5 mm of the hippocampal contours not previously treated
  7. * Pregnant or lactating women

Contacts and Locations

Study Contact

Lia M. Halasz
CONTACT
206-897-2121
lhalasz@uw.edu

Principal Investigator

Lia M. Halasz
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Lia M. Halasz, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Breast Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Leptomeninges
  • Stage IV Lung Cancer AJCC v8