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New treatment option for Meningioma
Official title Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
ClinicalTrials.gov ID: NCT06557512
What this study is testing
- What it's testing
- This clinical trial tests the safety and effectiveness of hypofractionated stereotactic radiosurgery for treating patients who have undergone surgical resection for grade II meningiomas or grade I meningiomas that have come back after a period of improvement (recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors.
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
- Age \>+ 18 years at time of study entry
- Ability to understand and the willingness to sign a written informed consent document.
- Histologic diagnosis of newly diagnosed World Health Organization (WHO) grade 2 or recurrent WHO grade 1 meningioma. With regard to recurrent WHO...
- Participants must have undergone a gross-total surgical resection as deemed by their neurosurgeon (Simpson grade I-III resection), using all...
- Participants must have a pre-operative MRI.
You likely can't join if
- Concurrent participation in another clinical study with an investigational product unless it is an observational (non-treatment) study or the...
- Extensive multifocal (3 or more meningiomas) or metastatic disease.
- Participants with tumors within 2mm of the optic apparatus or brainstem will be excluded.
- Participants with another active primary malignancy or history of previous malignancy (except non-melanoma skin cancers, low and...
- Female participants who are pregnant.
- Any underlying medical or psychiatric condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or...
See the full eligibility criteria
- Age \>+ 18 years at time of study entry
- Ability to understand and the willingness to sign a written informed consent document.
- Histologic diagnosis of newly diagnosed World Health Organization (WHO) grade 2 or recurrent WHO grade 1 meningioma. With regard to recurrent WHO grade 1 meningioma, participants must present with radiographic evidence...
- Participants must have undergone a gross-total surgical resection as deemed by their neurosurgeon (Simpson grade I-III resection), using all available information which can include post-operative MRI, of a meningioma...
- Participants must have a pre-operative MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score of 70 or higher)
- Participants must have post-operative MRI indicating anatomy suitable for hypofractionated radiosurgery, as reviewed by the Radiation Oncology co-principal investigators (PIs).
- Concurrent participation in another clinical study with an investigational product unless it is an observational (non-treatment) study or the follow-up period of an treatment study.
- Extensive multifocal (3 or more meningiomas) or metastatic disease.
- Participants with tumors within 2mm of the optic apparatus or brainstem will be excluded.
- Participants with another active primary malignancy or history of previous malignancy (except non-melanoma skin cancers, low and favourable-intermediate risk prostate cancers, and in situ cancers such as bladder...
- Female participants who are pregnant.
- Any underlying medical or psychiatric condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results.
- Participants with uncontrolled seizures, defined as greater than 3 disabling seizures per day while on anti-epileptic drugs.
- Participants who have had previous intracranial radiotherapy overlapping with the area that would be targeted for stereotactic radiosurgery by this study.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
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 San Francisco, California, United States. 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.