Proton/Photon Rt - Benign Meningiomas(P92-13)

Last updated: May 15, 2017
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

3

Condition

Brain Cancer

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT02947984
97-550
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age 18 or over

  • Histological documentation of benign meningioma

  • Documentation by imaging studies (CT and/ or MRI) or residual or recurrentintracranial tumor

  • Karnofsky performance status of ≥ 70

  • Study specific informed consent

Exclusion

Exclusion Criteria:

  • Malignant meningiomas

  • Prior cranial irradiation, except treatment of localized skin cancer of the face orscalp

  • Patients having a concurrent primary cancer (except skin)

  • Patients having another cancer controlled < 3 years

  • Pregnant patients

Study Design

Total Participants: 44
Study Start date:
March 01, 1999
Estimated Completion Date:
September 30, 2016

Study Description

  • After initial interview and physical examination, an immobilization device (head mask, neck support, back support, etc.) will be made for the participant. A treatment planning CT will be performed and a radiation treatment plan will be based on this CT scan.

  • The radiation dose will usually be given once a day, five days per week. The radiation treatment will take between 7 and 8 1/2 weeks, including treatment planning.

  • Treatment doses will vary, and the dose each participant will receive will be made on the basis of random assignment. Participants will either receive the usual dose of 55.8 CGE in 31 treatments or 1.8 CGE, or 63 CGE in 35 treatments of 1.8 CGE.

Connect with a study center

  • Massachusetts General Hosital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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