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)

Phase 2

Recruiting

• Conditions: Adult brain stem gliomas; Adults with non-contrast-enhancing diffuse brainstem gliomas with non-threatening infiltrative clinical and/or radiological progression

• Registration Number: 2024-511862-35-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: Ongoing, 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

Trial Locations

Locations (24)

Institut de Cancérologie de l'Ouest - site d'Angers; 🇫🇷 ANGERS, France

CHU Amiens - Groupe Hospitalier Sud; 🇫🇷 AMIENS, France

Centre Hospitalier Et Universitaire De Limoges; 🇫🇷 Limoges Cedex 1, France

CHRU de Brest - Hôpital de la cavale Blanche; 🇫🇷 Brest, France

Hospital Foch; 🇫🇷 Suresnes, France

Hôpitaux Universitaires de Marseille Timone; 🇫🇷 Marseille, France

Institut Regional Du Cancer De Montpellier; 🇫🇷 Montpellier, France

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

CHU Rennes - Hôpital Pontchaillou- Centre Eugène Marquis; 🇫🇷 Rennes, France

Centre Hospitalier Universitaire Rouen; 🇫🇷 Rouen Cedex, France

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Institut de Cancérologie de l'Ouest - site d'Angers

🇫🇷ANGERS, France

Pierre Kubicek

Site contact

+33241352700

Pierre.kubicek@ico.unicancer.fr