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

NCT ID: NCT02947984

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2016-09-30

Brief 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.

Detailed 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.

Conditions

Benign Meningioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Treatment

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

Group Type: EXPERIMENTAL

Standard Treatment

Intervention Type: RADIATION

55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.

Higher Dose Treatment

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

Group Type: EXPERIMENTAL

Higher Dose

Intervention Type: RADIATION

55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.

Interventions

Standard Treatment

55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.

Intervention Type: RADIATION

Higher Dose

55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Helen A. Shih, MD

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen A Shih, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hosital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

97-550

Identifier Type: -

Identifier Source: org_study_id