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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Besancon | OTHER |
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Meningiomas with malignant components include grade II meningiomas (GIIM, the most common ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas. Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly in regards to performing, or not, radiotherapy after surgery. One other limitation in the literature is lack of data on health-related quality of life (HRQoL). Clinical trials for GIIM are very difficult to conduct. No results have been made available. Here, we propose to study clinical, pathological, radiological and therapeutic factors of an exhaustive population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to assess the impact of postoperative radiotherapy, or the absence of postoperative radiotherapy, on overall survival and on quality of life
Meningiomas with malignant components include grade II meningiomas (GIIM, the most common ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas. Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly in regards to performing, or not, radiotherapy after surgery. One other limitation in the literature is lack of data on health-related quality of life (HRQoL). Clinical trials for GIIM are very difficult to conduct. No results have been made available.
Main objective: to assess the impact of postoperative radiotherapy after GIIM surgery on overall survival (OS) in a population-setting study.
Secondary objectives (for GIIM and GIIIM):
Design of the study: nationwide population-based study analysis and patterns of care/quality of care study, for all cases of incident GIIM and GIIIM operated in Metropolitan France during the 2007-2010 period.
The methodology used is based on a multidisciplinary national network already established by the French Brain Tumor DataBase (FBTDB), with the active participation of societies involved in the French neuro-oncology and the "Inter Groupe Coopérateur en Neuro-Oncologie", labeled by the French National Cancer Institute.
The FBTDB has already identified all incident cases of GIIM (n=1046) and GIIIM (n=158) operated in Metropolitan France from 2007 to 2010.
The study proposed is a retrospective study based on the medical charts of all these patients.
Furthermore, for all surviving patients not lost to follow-up, the follow-up consultations will include a prospective HRQoL evaluation (cutoff date: 2019/11/30).
It will be conducted a systematic pathological review (with eventually additional biological work-up), and a study of prognostic factors (clinical, radiological, biological), treatments administered, OS, PFS.
Primary endpoint: OS. The statistical analysis (to answer to the main question) will concern all GIIM only.
Hypothesis:
Experimental group: Group of GIIM with postoperative radiotherapy (n=314). Control group: Group of GIIM with postoperative follow-up only (n=732). With a bilateral type I error of 5% (two-sided) and a statistical power of 80% we will be able to demonstrate that postoperative radiotherapy will be associated with a Hazard ratio (mortality risk) of 0.80.
Secondary endpoints (for GIIM and GIIIM):
It is expected to:
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| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Description: Assessing the impact of postoperative radiotherapy after surgery on overall survival (OS) in population-based study of GIIM patients. Overall survival, the primary endpoint of this study, is defined as the time from surgery (histological diagnosis) to the time of death from any cause. Alive Patients at the time of the final analysis or who became lost to follow-up will be censored at their last date of giving news | up to 10 years, since diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| the tumor growth | The tumor growth after surgery and other treatment (based on successive MRIs) will be determined by the volumetric velocity of the tumor growth (mm3/year) | up to 10 years, since diagnosis |
| Progression/Recurrence Free Survival, will be measured by month |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the quality of life | Change from baseline in patients with a I and II grade glioma, defined by quality-of-life parameters Health related Quality of Life will be assessed using EORTC QlQ C30 and BN 20 questionnaires, Europol EQ5D, and a specific questionnaire on professional and social activities. -EORTC QLQ-C30: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint -EORTC QLQ-BN20: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint
Score at baseline, The change in the Specific questionnaire on professional and social activities score from baseline to endpoint |
Inclusion Criteria :Patient with a GIIM incident (atypical, chordidic and clear cell meningiomas) and GIIIM (anaplastic, papillary and rhabdoid meningiomas) operated in metropolitan France during the period 2007-2010
Exclusion Criteria :
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All patients with a histological diagnosis of GIIM and GIIIM in metropolitan France
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LUC BAUCHET, MD, PhD | Contact | 467337205 | 33 | l-bauchet@chu-montpellier.fr |
| Frank BONNETAIN | Contact |
| Name | Affiliation | Role |
|---|---|---|
| LUC BAUCHET, MD, PhD | UH MONTPELLIER | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uh Montpellier | Recruiting | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| up to 10 years, since diagnosis |
| baseline, 6 months, 12 months 18 months |
| diagnosis of the central pathological review. | Concordance/discordance analysis between the initial histological diagnosis and the diagnosis of the central pathological review. | 1 day |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |