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 progressio

Phase 1

• Conditions: adult brainstem gliomas; MedDRA version: 20.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002654-79-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 < 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified