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Proton Therapy

Proton vs Photon Radiation for Meningeal Carcinomatosis

Phase 2
Waitlist Available
Led By T. Jonathan Yang, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate bone marrow function: Hemoglobin > 8g/dL, Absolute neutrophil count >1,000/mm, Platelet count > 100,000/mm
Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying proton craniospinal radiation therapy to see if it is more effective than partial photon radiation therapy in preventing leptomeningeal metastasis from worsening.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with radiation therapies such as fatigue, skin irritation at treatment sites, nausea, hair loss in treated areas, headaches, and potential damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show normal levels of hemoglobin, neutrophils, and platelets.
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My cancer has spread to the lining of my brain and 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 over 16 and can care for myself most of the time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CNS progression free survival
Secondary outcome measures
Upper arm

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment3 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 Treatment3 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 Treatment3 Interventions
Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,706 Total Patients Enrolled
2 Trials studying Metastases
384 Patients Enrolled for Metastases
Fred Hutchinson Cancer CenterOTHER
555 Previous Clinical Trials
1,334,624 Total Patients Enrolled
T. Jonathan Yang, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
205 Total Patients Enrolled

Media Library

Proton Craniospinal Irradiation (CSI) (Proton Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04343573 — Phase 2
Metastases Research Study Groups: Standard of Care, Proton CSI Followed by Standard of Care (Other Solid Tumors), Proton CSI Followed by Standard of Care (NSCLC & Breast)
Metastases Clinical Trial 2023: Proton Craniospinal Irradiation (CSI) Highlights & Side Effects. Trial Name: NCT04343573 — Phase 2
Proton Craniospinal Irradiation (CSI) (Proton Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04343573 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolment for this research program still accepting participants?

"From what is stated on clinicaltrials.gov, this trial has stopped recruiting candidates. Despite the closure of recruitment for this particular study, there are 640 other medical trials looking to enrol patients at present."

Answered by AI

Is Proton Craniospinal Irradiation (CSI) a reliable procedure with minimal risk to patients?

"The safety of Proton Craniospinal Irradiation (CSI) was rated a 2 on the 1-3 scale due to the Phase 2 nature of this trial, which has some evidence supporting its safety but none suggesting efficacy."

Answered by AI

Which venues are currently hosting this research endeavor?

"Presently, 10 clinical trial sites are hosting this study. These locations span from Basking Ridge to Harrison and Middletown amongst other cities. Therefore, it is paramount that prospective participants select the closest site in order to mitigate their transit requirements."

Answered by AI
~0 spots leftby Apr 2024