A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas (NCT02693990) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
United States21 participantsStarted 2016-02
Plain-language summary
This research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have either:
* 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 gross total resection.
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.
Patients may or may not have neurofibromatosis type 1 or 2.
* Age 18 years or older.
* ECOG performance status ≤ 2 (Karnofsky Performance Status ≥ 60, see Appendix A)
* The effects of proton radiation therapy on the developing human fetus are known to be teratogenic. For this reason, women of child-bearing potential and all men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of proton therapy.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Participants may n…
What they're measuring
1
Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0