Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo blood and CSF sample collection
- RadiationCraniospinal Irradiation
Undergo photon-VMAT-CSI
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureLumbar Puncture
Undergo LP
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureOmmaya Reservoir Tap
Undergo Ommaya reservoir tap
- OtherQuestionnaire Administration
Ancillary studies
- RadiationVolume Modulated Arc Therapy
Undergo photon-VMAT-CSI
Outcome measures
Primary
Central nervous system (CNS)-progression free survival
Will be estimated using the Kaplan-Meier estimator, and its associating 95% confidence limit will be calculated using the logit transformation and the Greenwood variance estimate.
Time frame: From start of treatment to CNS relapse, CNS progression, death (from any cause), or last contact, whichever occurs first, assessed up to 1 year
Secondary
Radiographic response
Time frame: Every 3 months after treatment until CNS disease progression or death, assessed up to 1 year
Quality of life
Time frame: At baseline, 1 month, and every 3 months until CNS disease progression or death, assessed up to 1 year
Incidence of adverse events
Time frame: Up to 30 days after the last day of treatment
Overall survival
Time frame: From start of treatment to death (from any cause), or last contact, whichever occurs first, assessed up to 1 year
Eligibility criteria
Study locations (2)
City of Hope Medical Center
Duarte, California, 91010
City of Hope at Irvine Lennar
Irvine, California, 92618