NCT06910761

Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer

Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (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 and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. 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. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of photon-VMAT-CSI; assessed by median central nervous system progression free survival (CNS-PFS). SECONDARY OBJECTIVES: I. To estimate and assess central nervous system (CNS) response rate, response duration, and overall survival probability. II. To summarize and assess toxicities including: type, frequency, severity, attribution, time course and duration. III. To characterize and evaluate patient reported outcomes (PROs), including quality of life (QOL), measures: IIIa. QOL Questionnaire Brain 20 (European Organization for Research and Treatment of Cancer \[EORTC\]-Quality of Life Questionnaire \[QLQ\]-Brain 20 \[BN20\]); IIIb. Core QOL Questionnaire 30 (EORTC-QLQ-Core 30 \[C30\]); IIIc. Patient reported outcomes measurement information system (PROMIS) for Anxiety; IIId. PROMIS Cognition. EXPLORATORY OBJECTIVES: I. To characterize inflammatory markers over time. II. To explore the potential association between inflammatory markers and radiation-related toxicity. III. To evaluate the potential association between circulating cell-free deoxyribonucleic acid (cfDNA), imaging, and response. IV. To evaluate possible genomic predictors of CNS progression. OUTLINE: Patients undergo photon-VMAT-CSI once daily (QD) for 10 treatments over 10-20 days (Monday-Friday) in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) during screening and follow-up and undergo collection of blood samples throughout the trial. Patients also undergo lumbar puncture LP or Ommaya reservoir tap for cerebrospinal fluid (CSF) sample collection during screening and follow-up. After completion of study treatment, patients are followed up at 1 month and then every 3 months for up to 1 year.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood and CSF sample collection
RADIATION	Craniospinal Irradiation	Undergo photon-VMAT-CSI
OTHER	Electronic Health Record Review	Ancillary studies
PROCEDURE	Lumbar Puncture	Undergo LP
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Ommaya Reservoir Tap	Undergo Ommaya reservoir tap
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Volume Modulated Arc Therapy	Undergo photon-VMAT-CSI

Timeline

• Start date: 2025-05-05
• Primary completion: 2028-10-02
• Completion: 2028-10-02
• First posted: 2025-04-04
• Last updated: 2025-12-08

Locations

2 sites across 1 country: United States