Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03180268 : Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- PRIOR TO STEP 1 REGISTRATION:

- The patient must have a newly diagnosed unifocal intracranial meningioma, gross
totally resected, and histologically confirmed as WHO grade II based upon pathology
findings at the enrolling institution; WHO grade will be assigned according to WHO
2016 criteria

- Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without
gross residual dural-based or extradural tumor; GTR must be confirmed both by modified
Simpson grade and by post-operative magnetic resonance imaging (MRI) findings

- Step 1 registration must occur within 180 days of the initial surgery; within this 180
day interval, a second surgery is permitted in order to achieve GTR, but even with a
second surgery, step 1 registration must occur within 180 days of the initial
resection

- For step 1 registration the operating neurosurgeon must provide the modified Simpson
grade

- GTR must be confirmed on post-operative imaging following the most recent surgery;
submission of both pre-operative and post-operative MRIs is required for patients; if
a second surgery is performed, submission of post-operative MRI is required and
pre-operative MRI is required only if obtained; all sequences obtained in the pre- and
post-operative MR imaging are to be submitted to National Radiology Group (NRG)
Oncology for study registration; imaging subsequent to enrollment must include pre and
post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR),
magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI
scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield
acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR,
MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness
not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time
to permit step 1 registration within 180 days of the initial resection; these same
conditions apply in the setting of a second surgical procedure, although if a second
surgery is completed, step 1 registration must still occur with 180 days of initial
surgery; computed tomography (CT) imaging is not required, but may be obtained if
desired clinically, for instance to assess calcifications or hyperostosis

- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry

- If the patient is a primary English speaker, the patient must participate in the NCF
and patient reported outcomes part of the study; if the patient is a primary French or
Spanish speaker, the patient must participate in the patient reported outcomes part of
the study

- NOTE: Central pathology review must occur between steps 1 and 2 of registration; once
appropriate pathology specimens are received, central pathology review will occur
within 15 days, and must confirm WHO grade II meningioma before the patient can
proceed to step 2 registration and randomization

- PRIOR TO STEP 2 REGISTRATION:

- Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central
pathology review prior to step 2 registration

- History/physical examination, including neurologic examination within 60 days prior to
step 2 registration

- Post-operative Zubrod performance status 0-1 within 60 days prior to step 2
registration

- If the patient is a woman is of childbearing potential, a serum pregnancy test,
obtained within 14 days prior to step 2 registration, must be negative, and, if
randomized to receive radiation therapy, the woman must agree to use contraception

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) unless disease free
for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix,
melanoma in situ, or other non-invasive malignancies are permissible)

- 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; these include, but are not restricted to:

- Unstable angina and/or congestive heart failure requiring hospitalization at the
time of step 2 registration

- Transmural myocardial infarction within the last 6 months prior to step 2
registration

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of step 2 registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of step 2
registration

- Type II neurofibromatosis (NF2)

- Ailments entailing substantial increases in sensitivity and side effect risk from
radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human
immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing
is not required for eligibility for this protocol, and known HIV positive
patients are eligible, provided they are under treatment with highly active
antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter
within 30 days prior to step 2 registration

- Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI
compatible implant or foreign body, etc) or receive gadolinium; note that
patients with severe claustrophobia are permitted on this study if they are
willing and able to undergo MRI with adequate sedation or anesthesia

- Pregnancy and/or nursing females
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