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New treatment option for Grade 2 Meningioma
Official title Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
ClinicalTrials.gov ID: NCT03180268
What this study is testing
- What it's testing
- This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor. GTR must be...
- Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of...
- GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at...
You likely can't join if
- Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
- Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral...
- 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...
- Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration
See the full eligibility criteria
Who can join
- 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...
- 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...
- Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it...
- GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, submission of both pre-operative and post-operative...
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- 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 10 business days, and must confirm WHO grade...
- PRIOR TO STEP 2 REGISTRATION:
- Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
- Age \>= 18
- 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 assigned by chance to receive radiation therapy, the woman...
What rules you out
- Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
- Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)
- 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...
- 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...
- 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...
- Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium-...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Anaheim, California, United States
- Auburn, California, United States
- Bellflower, California, United States
- Dublin, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Ontario, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Rancho Cordova, California, United States
- Rohnert Park, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Clara, California, United States
+ 161 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Anaheim, California, United States; Auburn, California, United States and 175 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.