Comparing Observation vs Radiation for Newly Diagnosed Grade II Meningiomas that have been Completely Removed through Surgery

Research Study on Observation vs. Radiation Therapy After Surgery for Grade II Meningioma

Recruiting
18 years - 100 years
All
Phase 3
15 participants needed
1 Location

Brief description of study.

The purpose of this study is to compare the approach of observation with that of treating with radiation following surgery of a grade II meningioma.

Detailed description of study

Participants will be randomly assigned following surgery to either receive observation or to receive radiation therapy. Participants who receive radiation will do so 5 days per week for 6 1/2 to 7 weeks (33 treatments).

The doctor will continue to monitor the condition of all participants through office visits at months 3, 6 and 12 for the first year from randomization, every 6 months for year 2 and 3, then yearly for 10 years. Participants in both groups will also have MRIs at least every 6 months from randomization for 5 years, then at least yearly for 10 years.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Grade II Meningioma
  • Age: 18 years - 100 years
  • Gender: All

Individuals at least 18 years of age with a newly diagnosed grade II meningioma that has been completely removed through surgery.

Individuals with prior invasive malignancy or evidence of metastatic meningioma will not be eligible.

Individuals with certain major medical illnesses will not be eligible.

Updated on 19 Feb 2024. Study ID: 1810162883

This study investigates the effects of two different approaches after surgery for grade II meningioma, a type of brain tumor. The purpose of this study is to compare the outcomes of observation alone versus radiation therapy following surgery. Participants will be randomly assigned to either continue with observation or receive radiation therapy, which involves the use of high-energy rays to target and kill cancer cells.

Participants who are assigned to the radiation therapy arm will receive treatment 5 days a week for approximately 6 1/2 to 7 weeks, totaling 33 treatments. All participants, regardless of their assigned arm, will have regular office visits and MRI scans to monitor their condition over time. MRI, or Magnetic Resonance Imaging, is a test that uses magnets and radio waves to take pictures of organs and structures inside the body.

  • Who can participate: Adults aged 18 and older with a newly diagnosed grade II meningioma that has been completely removed through surgery are eligible. Individuals with prior invasive cancer, metastatic meningioma, or certain major medical illnesses are not eligible.
  • Study details: Participants will be randomly assigned to one of two study arms: observation or radiation therapy. Radiation therapy involves receiving high-energy rays 5 days a week for about 7 weeks. All participants will have regular MRI scans, a type of imaging test, to monitor their condition. This study does not involve a placebo.

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