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

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Benign Meningioma

Treatments: Radiation: Standard Treatment; Radiation: Higher Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02947984

97-550

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Standard Treatment

Experimental group

Description:

Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.

Treatment:

Radiation: Standard Treatment

Higher Dose Treatment

Experimental group

Description:

63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.

Treatment:

Radiation: Higher Dose