Status:
UNKNOWN
Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
OBJECTIVES: Primary * To assess the impact of high-dose radiotherapy (RT) on progression-free survival (PFS), treatment tolerance, and post-treatment global cognitive functioning in patients with at...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00626730
Start Date
December 1 2007
Last Update
February 3 2021
Active Locations (1)
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1
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211