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Proton Beam Therapy

Craniospinal Irradiation for Breast and Lung Cancer

Phase 2

Waitlist Available

Led By Lia M. Halasz

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and/or through CSF cytology

Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases

Must not have

Previous radiotherapy to the intended treatment site that precludes developing a treatment plan respecting normal tissue tolerances

Gross ventricular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the effectiveness of a specific type of radiation therapy, called craniospinal irradiation (CSI) with hippocampal avoidance, in treating patients with breast cancer or non-small

Who is the study for?

This trial is for patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread to the cerebrospinal fluid and meninges. Participants must have a life expectancy of more than 8 weeks, be able to undergo radiation therapy, and provide tissue samples from previous biopsies.

What is being tested?

The study tests craniospinal irradiation (CSI) with hippocampal avoidance using proton therapy or volumetric modulated arc therapy (VMAT). It aims to treat leptomeningeal metastases effectively while minimizing neurological side effects by sparing the hippocampus during radiation.

What are the potential side effects?

Potential side effects include typical reactions to radiation like fatigue, skin irritation, hair loss in treated areas, nausea, and headaches. Specific concerns involve reducing harm to the hippocampus to prevent significant neurological issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread to the lining of my brain or spinal cord.

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I am a candidate for radiation therapy to treat cancer spread to the lining of my brain and spinal cord.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

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I am not pregnant or meet specific reproductive health criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had radiation before where they now want to treat me, and can't have more without risking harm.

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I have a visible heart disease.

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My cancer is widespread and I have no suitable treatment options left.

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I have untreated brain metastases close to my hippocampus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Central nervous system (CNS)-progression free survival (PFS)

Secondary study objectives

Neurocognitive function assessment

Number of adverse events associated with hippocampal avoidance craniospinal irradiation (HA-CSI)

Overall survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Proton or Photon VMAT CSI)Experimental Treatment9 Interventions

Patients undergo proton or photon VMAT CSI with HA over approximately 45 minutes once daily (QD) for 10 days (Monday-Friday) in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening, as well as additional CT for radiation planning during screening. Additionally, patients undergo magnetic resonance imaging (MRI) throughout the trial. They may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal fluid (CSF) collection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Volume Modulated Arc Therapy

2017

Completed Early Phase 1

~30