Proton vs Photon Radiation for Meningeal Carcinomatosis

Recruiting at 9 trial locations

Overseen By T. Jonathan Yang, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Neurologic deficits, Extensive systemic disease, others

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

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

Compensation: Varies

Number of Visits: 10

102 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy. Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.

Research Team

Divya Yerramilli, MD, MBD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for people of all ages with solid tumor cancers that have spread to the lining of the brain and spine. They must be able to perform daily activities reasonably well (KPS ≥ 60 or Lansky ≥ 60), have adequate bone marrow function, and not be pregnant. Participants should agree to use effective contraception and be candidates for radiation therapy.

Inclusion Criteria

My blood tests show normal levels of hemoglobin, neutrophils, and platelets.

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

I am not pregnant and agree to use birth control during the study.

Exclusion Criteria

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

Pregnant or lactating women

Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive either proton craniospinal irradiation (proton CSI) or involved-field photon radiation therapy

2 weeks

10 visits (in-person)

Standard of Care Systemic Treatments

Participants receive standard of care systemic treatments for leptomeningeal metastases per physician choice

Follow-up

Participants are monitored for overall survival and CNS progression-free survival

2 years

Treatment Details

Interventions

• Involved-field Photon Radiation Therapy
• Proton Craniospinal Irradiation (CSI)

Trial Overview The study compares two types of radiation therapy: proton craniospinal irradiation (proton CSI) which targets the entire area around the brain and spinal fluid, versus partial photon radiation therapy that only treats symptomatic areas. The goal is to see which method better prevents worsening of cancer spread in these regions.

Participant Groups

Group I: Standard of Care Experimental Treatment 3 Interventions

Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.

Group II: Proton CSI Followed by Standard of Care (Other Solid Tumors) Experimental Treatment 3 Interventions

(Exploratory arm) Patients with solid tumor malignancies other than NSCLC or breast cancer will be enrolled to the exploratory proton CSI arm (Arm C) and will not undergo randomization. Proton CSI (30Gy \[RBE\] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.

Group III: Proton CSI Followed by Standard of Care (NSCLC & Breast) Experimental Treatment 3 Interventions

Proton CSI (30Gy \[RBE\] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+