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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033559
Receipt No. R000038267
Scientific Title PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA
Date of disclosure of the study information 2018/07/31
Last modified on 2019/01/29

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Basic information
Public title PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA
Acronym PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA (NRG-BN003)
Scientific Title PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA
Scientific Title:Acronym PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA (NRG-BN003)
Region
Japan North America

Condition
Condition GRADE II MENINGIOMA
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes PFS
Key secondary outcomes ・ PFS rates at 3 years and 5 years
・ Disease-specific survival (DSS) and DSS rates at 3 years and 5 years
・ Overall survival (OS) and OS rate at 5 years
・ Adverse events, 3-year toxicity as measured by the CTCAE v4 (exclusive of alopecia)
・ Adherence to protocol-specific target and normal tissue parameters
・ Concordance measurements of central versus parent-institution pathology
・ Assessment of pHH3 mitotic index correlates to PFS and OS
・ Neurocognitive (NCF) and patient reported outcome (PRO)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Arm 1: Observation
Interventions/Control_2 Arm 2: Radiation Therapy (IMRT or Protons)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ・ Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review
・ Age >= 18;
・ History/physical examination
・ Post-operative Zubrod Performance Status 0-1
・ If the patient is a woman of childbearing potential, a serum pregnancy test must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception
Key exclusion criteria ・ Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
・ Definitive evidence of metastatic meningioma
・ Prior invasive malignancy (except non-melanomatous skin cancer)
・ Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas
・ Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent.
Target sample size 148

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Leland Rogers
Organization Barrow Neurological Institute
Division name Radiation Oncology
Zip code
Address 350 W.Thomas Road, Phoenix, Arizona 85013
TEL +1-602-406-3170
Email lelandrogers@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Nishikawa
Organization Saitama Medical University International Medical Center
Division name Department of Brain and Spinal Cord Tumor
Zip code
Address 1397-1, Yamane, HIdaka-city, Saitama
TEL 042-984-4111
Homepage URL
Email nrg-japan@newkast.or.jp

Sponsor
Institute NRG Oncology
Institute
Department

Funding Source
Organization National Cancer Institute (NCI)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization U.S.A

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT03180268
Org. issuing International ID_1 National Institutes of Health (NIH)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉医科大学国際医療センター(埼玉県)、北海道大学病院(北海道)、岩手医科大学附属病院(岩手県)、国立がん研究センター中央病院(東京都)、慶應義塾大学病院(東京都)、広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 30 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038267

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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