View Clinical Trial (Medical Research Study)
Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas
| City: |
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Ogden |
| State: |
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Utah |
| Zip Code: |
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84403 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case,
observation may be sufficient. Specialized radiation therapy that delivers a high dose of
radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and
intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to
normal tissue. It is not yet known whether observation is more effective than radiation
therapy in treating patients with meningioma.
PURPOSE: This phase II trial is studying observation to see how well it works compared with
radiation therapy in treating patients with grade I, grade II, or grade III meningioma.
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| Study Summary: |
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OBJECTIVES:
Primary
- 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.
Secondary
- 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
parameters.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 groups according to
risk.
- 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
weeks.
- Group 3 (high-risk disease): Patients undergo IMRT once daily 5 days a week for 6
weeks.
After completion of study treatment, patients are followed up every 3-6 months for 3 years
and then annually for 10 years.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- 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
months
- 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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the scalp, cranium, brain, or skull base
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| NCT ID: |
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NCT00895622 |
| Primary Contact: |
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Study Chair
C. Leland Rogers, MD
Salt Lake Regional Medical Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Ogden, Utah 84403
United States
Clinical Trials Office - McKay-Dee Hospital Center
Phone: 801-387-7426
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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