Phase 3
N=44
Proton/Photon Rt - Benign Meningiomas(P92-13)
Benign Meningioma
Bottom Line
View on ClinicalTrials.gov: NCT02947984 ↗Enrolled (actual)
44
Serious AEs
13.6%
Results posted
Jun 2017
Primary outcome: Primary: Progression Free Survival — 91; 91; 86; 81 percentage of participants surviving — p=0.234
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard Treatment (Radiation); Higher Dose (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
91; 91; 86; 81; 52; 70 | 0.234 |
| SECONDARY Acute Toxicities |
2; 1; 1; 0; 2; 0 | — |
| SECONDARY Late Toxicities |
5; 2; 5; 1; 1; 3 | — |
| SECONDARY Local Failure Rate |
3; 2; 0; 1; 3; 1 | — |
Summary
The purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. This research study is designed to determine whether a higher dose of radiation will decrease the likelihood that the tumor will grow back, compared to the probability of re-growth that occurs after standard radiation doses.
Eligibility Criteria
Inclusion Criteria
- Age 18 or over
- Histological documentation of benign meningioma
- Documentation by imaging studies (CT and/ or MRI) or residual or recurrent intracranial tumor
- Karnofsky performance status of ≥ 70
- Study specific informed consent
Exclusion Criteria
- Malignant meningiomas
- Prior cranial irradiation, except treatment of localized skin cancer of the face or scalp
- Patients having a concurrent primary cancer (except skin)
- Patients having another cancer controlled < 3 years
- Pregnant patients
Data sourced from ClinicalTrials.gov (NCT02947984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.