Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-03 @ 6:48 PM
Study NCT ID:
NCT06910761
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-02015 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 23911 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |