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Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas



- To estimate the rates of progression-free survival at 3 years in patients with low-risk
meningioma undergoing observation and in patients with intermediate- or high-risk
meningioma undergoing radiotherapy.


- To study the concordance, or lack thereof, between central and parent institution
histopathologic diagnosis, grading, and subtyping.

- To estimate the rates of overall survival at 3 years in these patients.

- To estimate the incidence rates of acute and late adverse events ≥ grade 2 in patients
with intermediate- or high-risk meningioma undergoing radiotherapy.

- To evaluate MRI imaging predictors by central neuroradiology review at diagnosis, at
any failure, and at 3 years.

- To evaluate adherence to protocol-specific target and normal tissue radiotherapy

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 groups according to

- Group 1 (low-risk disease): Patients undergo observation.

- Group 2 (intermediate-risk disease): Patients undergo 3-dimensional conformal
radiotherapy or intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6

- Group 3 (high-risk disease): Patients undergo IMRT once daily 5 days a week for 6

After completion of study treatment, patients are followed up every 3-6 months for 3 years
and then annually for 10 years.

Inclusion Criteria


- Histologically confirmed meningioma, meeting 1 of the following criteria:

- Low-risk disease, as defined by the following:

- Newly diagnosed, WHO grade I disease that was gross totally resected
(Simpson's grade I, II, or III resection with no residual nodular
enhancement on postoperative imaging) or subtotally resected (residual
nodular enhancement or Simpson grade IV or V resection)

- Intermediate-risk disease, as defined by the following:

- Newly diagnosed, WHO grade II disease that was gross totally resected OR
recurrent WHO grade I disease irrespective of the resection extent

- High-risk disease, as defined by 1 of the following:

- Newly diagnosed or recurrent WHO grade III disease of any resection extent

- Recurrent WHO grade II disease of any resection extent

- Newly diagnosed, WHO grade II disease that was subtotally resected

- Patients with newly diagnosed disease must have had a histologic diagnosis within the
past 6 months AND have undergone pre- and post-operative MRIs within the past 3

- Patients with recurrent/progressive intermediate- or high-risk disease who have not
undergone recent surgery must have documentation of recurrence or progression by MRI
within the past 3 months

- No extracranial or multiple meningioma and/or hemangiopericytoma


- Zubrod performance status 0-1

- Negative pregnancy test (for patients enrolled in groups 2 or 3)

- Fertile patients must use effective contraception (for patients enrolled in groups 2
or 3)

- Able to receive gandolinium

- No other invasive malignancy within the past 3 years except for nonmelanoma skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- No severe, active comorbidity including, but not limited to, any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization

- Transmural myocardial infarction within the past 6 months

- Acute bacterial and/or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or respiratory illness
requiring hospitalization or that would preclude study treatment

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Known HIV positivity or AIDS, based upon the current CDC definition

- No evidence of active connective tissue disorders (e.g., lupus erythematosus
and/or scleroderma) (for patients enrolled in groups 2 or 3)

- No other major medical illness or psychiatric impairment that, in the investigator's
opinion, would preclude study treatment or informed consent


- See Disease Characteristics

- No prior radiotherapy to the scalp, cranium, brain, or skull base

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 3 years

Safety Issue:


Principal Investigator

C. Leland Rogers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Salt Lake Regional Medical Center



Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult grade I meningioma
  • adult grade II meningioma
  • adult grade III meningioma
  • adult anaplastic meningioma
  • adult papillary meningioma
  • recurrent adult brain tumor
  • Meningioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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