Proton Craniospinal Radiation for Cancer in the Brain and Spinal Cord

Recruiting at 58 trial locations

Overseen By Jonathan Yang

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NRG Oncology

Disqualifiers: Unstable angina, Myocardial infarction, NYHA III/IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

Duration: 2 weeks

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of radiation therapy for treating leptomeningeal metastasis, a condition where cancer spreads to the fluid around the brain and spinal cord. The trial tests proton craniospinal irradiation (pCSI), which targets the entire central nervous system more precisely, against involved-field radiation therapy (IFRT), which focuses on specific areas causing symptoms. Eligible patients have breast cancer or non-small cell lung cancer with leptomeningeal metastasis and can recognize symptoms like headaches, nausea, or vision changes. Participants must be candidates for radiation therapy and cleared for proton therapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to access potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that proton craniospinal irradiation (pCSI) is a promising treatment for leptomeningeal disease (LMD), which occurs when cancer spreads to the fluid around the brain and spinal cord. Studies have found that pCSI can be more effective than other types of radiation therapy, such as involved-field radiation therapy (IFRT), in extending the lives of patients with LMD.

Regarding safety, pCSI is generally well-tolerated. One study found that patients experienced fewer severe side effects compared to those who received standard radiation treatments. While all radiation treatments can cause side effects, pCSI's precise targeting of cancer cells helps reduce the risk of harming healthy tissues. This precision usually results in fewer negative effects, making it a safer option for some patients.

It is important to note that pCSI is still under study to fully understand its safety, especially in larger patient groups. However, current evidence suggests it could be a safer and more effective treatment for those with cancer that has spread to the brain and spinal cord. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cancer in the brain and spinal cord?

Researchers are excited about proton beam craniospinal irradiation because it offers a more targeted approach to treating cancer in the brain and spinal cord compared to traditional radiation therapies. Unlike conventional radiation, which can affect both cancerous and healthy tissues, proton therapy delivers precise radiation doses that minimize damage to surrounding healthy areas. This precision reduces side effects and potentially improves outcomes. Additionally, proton therapy might offer quicker results, as it targets the entire cerebrospinal fluid space, which is where cancer cells often spread.

What evidence suggests that proton craniospinal irradiation could be an effective treatment for leptomeningeal metastasis?

This trial will compare proton craniospinal irradiation (pCSI) with involved-field radiation therapy (IFRT) for treating cancer that spreads to the fluid around the brain and spinal cord. Research has shown that pCSI might be more effective than IFRT, as studies have found that patients receiving pCSI tend to live longer on average than those receiving traditional radiation. For example, one study reported that patients treated with pCSI lived about 9.9 months, while those treated with photon radiation lived about 6 months. Additionally, pCSI can better control cancer in the brain and spine, potentially delaying the worsening of symptoms. This treatment uses protons to target cancer more precisely, which might lead to fewer side effects and better results. ^{1 2 3 5 6}

Who Is on the Research Team?

Jonathan T Yang

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for adults with breast cancer or non-small cell lung cancer that has spread to the fluid around the brain and spinal cord. Participants must have a confirmed diagnosis, positive cerebrospinal fluid (CSF) cytology for malignancy, and be suitable candidates for radiation therapy.

Inclusion Criteria

I have not yet registered for Step 1.

My spinal fluid test shows cancer cells.

I have been diagnosed with breast cancer or NSCLC through a biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients undergo either involved-field radiation therapy (IFRT) or proton craniospinal irradiation (pCSI) 5 days a week for a total of 10 days

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Every 3 months

Long-term Follow-up

Participants continue to be monitored for overall survival and other outcomes

Up to 3 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Involved-Field Radiation Therapy
• Proton Beam Craniospinal Irradiation

Trial Overview The RADIATE-LM Trial compares proton craniospinal irradiation (pCSI), which targets the entire central nervous system more accurately, against involved-field radiation therapy (IFRT), which treats specific areas of leptomeningeal metastasis using x-rays.

How Is the Trial Designed?

Group I: Arm 2 (pCSI) Experimental Treatment 7 Interventions

Patients undergo pCSI radiation therapy delivered to the entire space containing the CSF, brain, and spinal cord 5 days a week for a total of 10 days of treatment in the absence of disease progression or unacceptable toxicity. Patients undergo CT or PET/CT during screening and MRI as well as possible LP throughout the study. Patients may optionally undergo research blood sample and CSF collection throughout the study.

Group II: Arm 1 (IFRT) Active Control 7 Interventions

Patients undergo involved-field radiation therapy delivered to specific areas of LM that are causing and/or may cause symptoms 5 days a week for a total of 10 days of treatment in the absence of disease progression or unacceptable toxicity. Patients undergo CT or PET/CT during screening and MRI as well as LP throughout the study. Patients may optionally undergo research blood sample and CSF collection throughout the study.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11940959/

Proton Craniospinal Irradiation for Patients with Solid Tumor ... We report one of the largest cohorts of patients with leptomeningeal disease treated with modern proton craniospinal irradiation at a large tertiary center.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025001122

Real-World Experience Using Proton Versus Photon ... Data demonstrate improved survival with proton craniospinal irradiation (CSI) over involved field radiation therapy for leptomeningeal disease (LMD). It is ...

3. mskcc.org mskcc.org/news/power-precision-proton-therapy-can-target-brain-spine-tumors-fewer-side-effects

Proton Beam Therapy Can Target Brain and Spine Tumors ... “The trial showed that proton craniospinal irradiation resulted in improved control of the cancer in the brain and spine, and better overall ...

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02618-7

Early experience with proton craniospinal irradiation in adult ... Recent data suggest proton craniospinal irradiation (pCSI) to be a promising treatment option, potentially prolonging progression-free survival (PFS) and ...

5. meridian.allenpress.com meridian.allenpress.com/innovationsjournals-JIPO/article/7/1/1/496372/Proton-Craniospinal-Irradiation-with-Immunotherapy

Proton Craniospinal Irradiation with Immunotherapy in Two ... Median OS for pCSI was 9.9 months (95% CI, 7.5–NA) compared with 6.0 months for photon RT (95% CI, 3.9–NA). Six patients in this trial had ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03520504

Study of Proton Radiation to the Brain and Spinal Cord for ... The researchers think that using proton beam radiation to treat the space containing CSF, brain, and spinal cord, instead of treating only the areas where the ...