Proton Craniospinal Radiation for Cancer in the Brain and Spinal Cord

Recruiting at 7 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

Trial Summary

What is the purpose of this trial?

This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.

Research Team

Jonathan T Yang

Principal Investigator

NRG

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+