Unique ID issued by UMIN | UMIN000033559 |
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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 |
PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA
PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA (NRG-BN003)
PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA
PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA (NRG-BN003)
Japan | North America |
GRADE II MENINGIOMA
Radiology | Neurosurgery |
Malignancy
YES
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.
Safety,Efficacy
Confirmatory
Phase III
PFS
・ 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)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Central registration
2
Treatment
Device,equipment |
Arm 1: Observation
Arm 2: Radiation Therapy (IMRT or Protons)
18 | years-old | <= |
Not applicable |
Male and Female
・ 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
・ 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.
148
1st name | Michael A. |
Middle name | |
Last name | Vogelbaum |
Moffitt Cancer Center
Department of Neuro-Oncology
33612
12902 USF Magnolia Drive, Tampa, FL 33612
+1-813-745-4251
Michael.Vogelbaum@Moffitt.org
1st name | Ryo |
Middle name | |
Last name | Nishikawa |
Saitama Medical University International Medical Center
Department of Brain and Spinal Cord Tumor
350-1298
1397-1, Yamane, HIdaka-city, Saitama
042-984-4111
nrg-japan@kuhs.ac.jp
NRG Oncology
National Cancer Institute (NCI)
Outside Japan
U.S.A
Saitama Med U International Med Ctr IRB
1397-1 Yamane, Hidaka-city, Saitama
042-984-4523
chikens@saitama-med.ac.jp
YES
NCT03180268
National Institutes of Health (NIH)
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)
2018 | Year | 07 | Month | 31 | Day |
Unpublished
Open public recruiting
2017 | Year | 06 | Month | 14 | Day |
2018 | Year | 08 | Month | 01 | Day |
2018 | Year | 08 | Month | 15 | Day |
2038 | Year | 05 | Month | 31 | Day |
2018 | Year | 07 | Month | 30 | Day |
2024 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038267
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