Brain and Central Nervous System Tumors Clinical Trial
Official title:
Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study
Verified date | February 2021 |
Source | European Organisation for Research and Treatment of Cancer - EORTC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying radiation therapy to see how well it works in treating patients who have undergone surgery for newly diagnosed grade II or grade III meningioma.
Status | Active, not recruiting |
Enrollment | 78 |
Est. completion date | |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed meningioma, including the following subtypes: - Atypical WHO grade II meningioma greater than or equal to 4 mitosis per high-power field [HPF] or the presence of at least 3 of the following variables: - Cellularity - Architectural sheeting (i.e., patternless pattern) - Macronuclei cell formation - Small cell formation - Malignant WHO grade III meningioma - All locations allowed except for optic nerve sheets tumors - Complete or subtotal resection as assessed by the surgeon after verification with a postoperative MRI and according to Simpson guidelines - No neurofibromatosis type 2 (NF-2) PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Not pregnant or nursing - Fertile patients must use effective contraception during study therapy - May be registered on this trial only once - No clinical evidence of second malignancies except carcinoma in situ of the cervix or basocellular carcinoma - No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: - No prior radiotherapy to the brain or meninges interfering with the protocol treatment plan |
Country | Name | City | State |
---|---|---|---|
Switzerland | Hopital Cantonal Universitaire de Geneve | Geneva |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | |||
Secondary | Adverse events as assessed by NCI CTCAE v3.0 | |||
Secondary | Mini-mental status exam | |||
Secondary | Overall survival |
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