Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study
18 Years
70 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study
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
atypical (WHO grade II) or malignant ( WHO grade III) meningioma.
OUTLINE: Patients with grade II disease are stratified according to resection status
(complete excision [Simpson's stages 1-3] vs incomplete excision [Simpson's stages 4-5]) and
participate in a phase II study. These patients are assigned to 1 of 2 treatment groups
according to Simpson staging. Only data from these patients is analyzed with respect to the
progression-free survival endpoint. Patients with grade III disease are treated in group 1
or 2 according to Simpson staging (as patients with grade II disease). After treatment, the
clinical results from these patients are observed and described.
- Group 1 (Simpson stage 1-3): Beginning no later than 6 weeks following surgery,
patients undergo radiotherapy once daily, 5 days a week for 6 weeks.
- Group 2 (Simpson stage 4-5): Beginning no later than 6 weeks following surgery,
patients undergo radiotherapy once daily, 5 days a week for 7 weeks.
Patients complete a Mini-Mental Status Exam at baseline and at 6 weeks and 6 months after
completion of study.
After completion of study treatment, patients are followed at 6 weeks, at 6 and 12 months,
and then annually for at least 3 years.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Damien C. Weber, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Cantonal Universitaire de Geneve
Authority:
Unspecified
Study ID:
CDR0000583070
NCT ID:
NCT00626730
Start Date:
December 2007
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult grade II meningioma
- adult grade III meningioma
- Meningioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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