TEMOTRAD 01 : First-line chemotherapy with temozolomide alone for non-enhancing adult brainstem gliomas, with a diffuse subtype and showing clinical and/or radiological infiltrative pattern of progression - TEMOTRAD01

Assistance Publique Hopitaux De Paris24 个研究点分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新: 2024年8月1日

试验速览

暂无简介。

•- 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 < 1.5 × ULN, AST and ALT< 2.5 x ULN
•- Serum creatinine < 1.5 × ULN
•- Effective contraception
•- Negative pregnancy test (serum beta-HCG) in females of reproductive age
•- Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- 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

发起方

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Dr Florence LAIGLE-DONADEY

Scientific

Assistance Publique Hopitaux De Paris

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