UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033559
Receipt number 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 2024/02/15 15:11:36

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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 Michael A.
Middle name
Last name Vogelbaum

Organization

Moffitt Cancer Center

Division name

Department of Neuro-Oncology

Zip code

33612

Address

12902 USF Magnolia Drive, Tampa, FL 33612

TEL

+1-813-745-4251

Email

Michael.Vogelbaum@Moffitt.org


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Nishikawa

Organization

Saitama Medical University International Medical Center

Division name

Department of Brain and Spinal Cord Tumor

Zip code

350-1298

Address

1397-1, Yamane, HIdaka-city, Saitama

TEL

042-984-4111

Homepage URL


Email

nrg-japan@kuhs.ac.jp


Sponsor or person

Institute

NRG Oncology

Institute

Department

Personal name



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

Saitama Med U International Med Ctr IRB

Address

1397-1 Yamane, Hidaka-city, Saitama

Tel

042-984-4523

Email

chikens@saitama-med.ac.jp


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)、杏林大学医学部付属病院(東京)、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

2018 Year 08 Month 01 Day

Anticipated trial start date

2018 Year 08 Month 15 Day

Last follow-up date

2038 Year 05 Month 31 Day

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

2024 Year 02 Month 15 Day



Link to view the page

Value
https://center6.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