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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0

Secondary outcome measures

Calculate Linear Energy Transfer Using Computer Simulations Based on the Treatment Plan

Overall Survival

The Absence of Progressive or Recurrent Disease

Other outcome measures

In Vivo Range of the Delivered Proton Pencil-Beams

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,385 Total Patients Enrolled

5 Trials studying Meningioma

150 Patients Enrolled for Meningioma

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,588 Total Patients Enrolled

45 Trials studying Meningioma

4,177 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

Frequently Asked Questions

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

Is there still availability to join this clinical experimentation?

"Affirmative. The clinicaltrials.gov website provides evidence that this research is actively recruiting individuals for participation as of August 17th, 2020. This project was initially published on February 1st, 2016 and requires 60 participants from two distinct sites to complete the study requirements."

Answered by AI

How many candidates are being admitted to this medical experiment?

"Affirmative. The clinicaltrials.gov website states that this medical trial remains active, having been initially posted on February 1st 2016 and most recently updated on August 17th 2020. 60 patients need to be recruited from two centres for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas

Helen A. Shih, MD 2016. "A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02693990.

All > Brain Cancer > Meningioma