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Proton Beam Therapy

IMPT for Brain Tumor

N/A
Recruiting
Led By Helen A Shih, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically confirmed atypical meningioma, WHO grade II, Simpson grade 4-5 that has been either subtotally resected or biopsied, or histologically confirmed malignant/anaplastic meningioma, WHO grade III with any prior surgery. In the case of recurrent radiographically gross disease, pathologic diagnosis may be from time of original biopsy and/or surgery. Pathology should be reviewed and confirmed at the Participating Institution.
ECOG performance status ≤ 2 (Karnofsky Performance Status ≥ 60, see Appendix A)
Must not have
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or lactating women are excluded from this study because radiation is known to have teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying if radiation therapy can be effective in treating meningioma, a tumor on the lining of the brain. The intervention being studied is Intensity Modulated Proton Therapy (IMPT).

Who is the study for?
Adults with high-grade meningiomas, a type of brain tumor, can join this trial. They must not be pregnant or breastfeeding and agree to use contraception. Participants should have an acceptable general health status (ECOG ≤ 2) and have had certain surgeries for their tumors. Those with other cancers may qualify if they've been cancer-free for 3 years.
What is being tested?
The trial is testing Intensity Modulated Proton Therapy (IMPT), a form of radiation therapy, as a treatment option for patients with atypical or malignant meningiomas that are WHO grade II/III after surgery.
What are the potential side effects?
While the information provided does not specify side effects, IMPT generally may cause fatigue, skin reactions at the treatment site, headaches, hair loss around treated area, nausea and potential cognitive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My meningioma is confirmed to be atypical or malignant by a biopsy.
Select...
I can care for myself but may not be able to do active work.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
I am not pregnant or breastfeeding.
Select...
I have never had radiation therapy to my head.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0
Secondary study objectives
Calculate Linear Energy Transfer Using Computer Simulations Based on the Treatment Plan
Overall Survival
The Absence of Progressive or Recurrent Disease
Other study objectives
In Vivo Range of the Delivered Proton Pencil-Beams

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Grade III (Malignant) Meningiomas, STRExperimental Treatment1 Intervention
Patient will be treated at a pre determined dose of Intensity Modulated Proton Therapy (IMPT) for the specific cohort.
Group II: Grade III (Malignant) Meningiomas, GTRExperimental Treatment1 Intervention
Patient will be treated at a pre determined dose of Intensity Modulated Proton Therapy (IMPT) for the specific cohort.
Group III: Grade II (Atypical) Meningiomas, STRExperimental Treatment1 Intervention
Patient will be treated at the starting dose of Intensity Modulated Proton Therapy (IMPT) which is pre-determined.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,308,960 Total Patients Enrolled
5 Trials studying Meningioma
150 Patients Enrolled for Meningioma
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,405 Total Patients Enrolled
46 Trials studying Meningioma
4,197 Patients Enrolled for Meningioma
Helen A Shih, MDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
207 Total Patients Enrolled
1 Trials studying Meningioma
44 Patients Enrolled for Meningioma

Media Library

Intensity Modulated Proton Therapy (IMPT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02693990 — N/A
Meningioma Research Study Groups: Grade II (Atypical) Meningiomas, STR, Grade III (Malignant) Meningiomas, GTR, Grade III (Malignant) Meningiomas, STR
Meningioma Clinical Trial 2023: Intensity Modulated Proton Therapy (IMPT) Highlights & Side Effects. Trial Name: NCT02693990 — N/A
Intensity Modulated Proton Therapy (IMPT) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02693990 — N/A
~4 spots leftby Aug 2025
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