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

NCT02947984 | Completed Phase 3 Results DMC

• 1 other identifier: 97-550
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Meningioma

Keywords

sphenoid region; parasellar area; photon radiation therapy; proton radiation therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.

  5, 10, 15 years

Secondary Outcomes (3)

• Acute Toxicities

  90 Days

• Late Toxicities

  5 Years

• Local Failure Rate

  15 Years

Study Arms (2)

Standard Treatment

EXPERIMENTAL

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

Radiation: Standard Treatment

Higher Dose Treatment

EXPERIMENTAL

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

Radiation: Higher Dose

Interventions

Standard Treatment 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.

Standard Treatment

Higher Dose 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hosital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Results Point of Contact

• Title: Nina Sanford, MD
• Organization: Massachusetts General Hospital

NSANFORD@PARTNERS.ORG

Study Officials

• Helen A Shih, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: October 28, 2016
• Study Start: March 1, 1999
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)