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)
This is a Phase I clinical trial. Researchers are trying to find out if using increased-dose intensity modulated proton therapy (IMPT) for treatment of Meningiomas will be more effective than the current treatment. The intensity modulated part of IMPT allows for even better concentration of the radiation dose to the desired target and less dose to the surrounding normal tissues than even traditional passive scattering proton therapy can do. Proton beams can be regulated to stop within or shortly beyond treatment targets. Therefore there is little exposure of the normal tissue to radiation. The FDA (the U.S. Food and Drug Administration) has not approved IMPT as a treatment for any disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Radiation Therapy - Intensity Modulated Proton Therapy (IMPT)
Massachusetts General Hospital
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0
Establish a safe increased-dose of post-operative IMPT with SIB in treating each of two meningioma cohorts: grade II (atypical) with subtotal resection and grade III (malignant) with gross total resection. Dose-limiting toxicity (DLT) using NCI CTC 4.0 will be assessed from the start of protocol treatment. The dose-seeking plan for each meningioma cohort will follow a modified 3+3 design with the starting and reduced doses for CTV and GTV.
Time frame: 2 years
The Absence of Progressive or Recurrent Disease
The duration of local tumor control will be measured from the start date of protocol treatment until the date of progressive or recurrent disease or censored at the date of last follow-up for patients still alive with stable disease. The rate of local failure will be estimated separately for each stratum based on the cumulative incidence, with death as a competing risk in the absence of progressive or recurrent disease.
Time frame: 5 years
Overall Survival
• Overall survival (OS) will be measured from the start date of protocol treatment until the date of death due to any cause or censored at the date of last follow-up for patients still alive. The rate of OS will be estimated separately for each stratum using the Kaplan-Meier method.
Time frame: 2 years
Calculate Linear Energy Transfer Using Computer Simulations Based on the Treatment Plan
• Linear energy transfer (LET) will be plotted against radiographic changes to assess the pattern of their correlation. Graphical methods and descriptive statistics will be used to determine if the relationship may be characterized by a formal model, possibly after data transformation. All strata will be pooled for the analyses of LET and the other physics endpoints, as they are functions of only the radiation physics, not histology or surgery.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.