adult brainstem gliomas MedDRA version: 20.0 Level: PT Classification code 10065443 Term: Malignant glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Temozolomide
Product Name: Temozolomide
Pharmaceutical Form: Cachet
INN or Proposed INN: temozolomide
CAS Number: 85622-93-1
Concentration unit: mg milligram(s)
Concentration type: up to
C
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years of age or older - IK over 50 - Non-enhancing lesion at MRI - Histologically proven infiltrative brainstem glioma with the following exception: " formal contraindication to surgery determined via discussion of the case with expert neurosurgeons during a national webmeeting (GLITRAD) This exception may lead to case-by-case inclusion despite the lack of a histologically-proven diagnosis if clinical and radiological evidence support such a diagnosis and if a very detailed systemic check-up, standardized by the GLITRAD group (spinal MRI, whole body CT, 18FDG PET-CT, LP (if feasible), blood inflammatory and infectious counts, biopsy of the salivary glands, etc) is negative and allows us to state that this diagnosis is highly probable - Clinical and/or radiological progression warranting antitumoral treatment - Absolute neutrophil count > 1.5 x 109/l, Platelets > 100 x 109/l - Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Pilocytic astrocytoma - Ependymoma - Lack of a histologically proven diagnosis or an uncertain diagnosis regarding the tumoral nature and/or glial nature of the lesion after the GLITRAD web meeting and a very detailed checkup looking for diagnostic pitfalls - Contrast enhancement on MRI - Rapidly progressive and severe clinical deterioration and/or radiological progression occurring with a threatening pattern, defined as an evolution of the tumoral infiltration with severe mass effect or herniation impacting the life expectancy - Previous radiotherapy or chemotherapy for this lesion - Predictable difficulty with follow-up - Systemic contraindications to temozolomide - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of this study is to assess the impact (objective response and PFS) of first-line chemotherapy in infiltrative non-enhancing adult brainstem gliomas that are progressing in an infiltrative and non-threatening way. Upon progression, RT will be administered.;Secondary Objective: This study will also improve our knowledge regarding this pathology in adults. Systematic biopsies, except in the case of formal contraindication, for every adult brainstem glioma will promote the following two objectives: obtainment of histological confirmation to avoid misdiagnosis at this location and collection of tissue for molecular analysis to define the histo-molecular profile of these tumors. In the future, a better characterization of these tumors should allow adult patients access to specific "targeted therapies", as in the pediatric population, especially at the time of recurrence. This project will also improve our radiological and metabolical knowledge of these tumors by systematic analysis via multimodal MRI and 18F-DOPA PET-CT performed before treatment and during follow-up. ;Primary end point(s): -Clinical and radiological response rates to temozolomide according to the RANO criteria transposed to infiltrating brainstem lesions -PFS based on the elapsed time between the beginning of chemotherapy and progression, which will require treatment by radiotherapy The objective is to reach a 3-year PFS of 30% (compared with 10% of patients after simple follow-up). ;Timepoint(s) of evaluation of this end point: first 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Histological pattern of adult brainstem gliomas - Molecular pattern of adult brainstem gliomas - Radiological pattern of adult brainstem gliomas based on standard and multimodal MRI - Metabolic pattern of adult brainstem gliomas based on 18F-DOPA PET CT at initial diagnosis and its change after treatment - Global survival - Quality of life (EORTC QLQ-C30 with BCM-20) - Tolerance to temozolomide - Volumetric velocity of the tumor growth during follow-up before treatment from the initial MRI until the last MRI before beginning of the treatment, established with sagittal cube FLAIR sequences - Volumetric velocity of the tumor growth during follow-up during treatment of chemotherapy, established with sagittal cube FLAIR sequences ;Timepoint(s) of evaluation of this end point: during all the trial | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed