Clinical Trial: Oncological Care for Patients With Meningioma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Postoperative Oncological Care for Patients With Meningioma With Malignant Components

Brief Summary: 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

Detailed Summary:

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):

  • Evaluate the recurrence/progression free survival (PFS), volumetric velocity of the tumor growth (VVTG) after surgery and other treatment.
  • Evaluate long term HRQoL.
  • Evaluate the relevance and impact of histopathological review in a population setting.
  • Looking for prognostic (clinical, radiological and biological) factors.
  • Proposing therapeutic decision trees in general or for certain categories of patients.
  • Identifying relevant cases to conduct further studies to identify new therapeutic targets.
  • Perspectives for the TUCERA network to help design specific prospective projects.
  • Looking for disparities in care management, survival and HRQoL in the various regions of France.

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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the tumor growth [ Time Frame: up to 10 years, since diagnosis ]
    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)
  • Progression/Recurrence Free Survival, will be measured by month [ Time Frame: up to 10 years, since diagnosis ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: October 17, 2016
Date Started: November 2016
Date Completion: December 2020
Last Updated: November 21, 2016
Last Verified: October 2016