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

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ClinicalTrials.gov Identifier: NCT02947984
Recruitment Status : Completed
First Posted : October 28, 2016
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Benign Meningioma Radiation: Standard Treatment Radiation: Higher Dose Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study Of Patients With Recurrent Or Incomplete Excised Benign Intercranial Meningiomas For The Evaluation Of Treatment Result With Combined Proton And Photon Irradiation To Doses 55.8 Or 63.0 CGE
Study Start Date : March 1999
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Treatment
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
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.

Experimental: Higher Dose Treatment
63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
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.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 5, 10, 15 years ]
    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.


Secondary Outcome Measures :
  1. Acute Toxicities [ Time Frame: 90 Days ]
    The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.

  2. Late Toxicities [ Time Frame: 5 Years ]
    The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.

  3. Local Failure Rate [ Time Frame: 15 Years ]
    The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947984


Locations
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United States, Massachusetts
Massachusetts General Hosital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Helen A Shih, MD Massachusetts General Hospital
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Responsible Party: Helen A. Shih, MD, Prinicipal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02947984    
Other Study ID Numbers: 97-550
First Posted: October 28, 2016    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helen A. Shih, MD, Massachusetts General Hospital:
sphenoid region
parasellar area
photon radiation therapy
proton radiation therapy
Additional relevant MeSH terms:
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Meningioma
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