Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2019
septembre 2023
04 mai 2025
This phase 2 study is a prospective cohort study. Chemotherapy alone will be proposed to
adult patients suffering from a "low grade" brainstem glioma subtype showing
infiltrative, non-threatening clinico-radiological progression. Patients will receive
temozolomide at a monthly standard dose of 150-200 mg/m2/j J1-J5, will be clinically
evaluated every month and will undergo radiological evaluation every 2 months. The
duration of treatment will be 12 months. Then, the patients will be followed-up until
progression, with clinical evaluations and MRI performed every 2-3 months. At the time of
recurrence, treatment with focal radiation therapy will be administered (54 Gy in
classical fractions).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | DONADEY Florence | 18/04/2025 07:56:33 | Contacter | ||
| HOPITAL FOCH | Nadia YOUNAN | 05/05/2025 07:12:03 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Groupe Hospitalier Pitié-Salpêtrière - 75013 - Paris - France | Florence LAIGLE-DONADEY, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 18 years of age or older
- Karnofsky's Index over 50
- Non-contrast lesion on MRI
- Histologically proven low grade brainstem glioma with 2 exceptions:
- formal contraindication to surgery determined via discussion of the case with
expert neurosurgeons during a national webmeeting (GLITRAD)
- negative brainstem biopsy These two exceptions 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, PET, 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 with an infiltrative but non-threatening
pattern, warranting antitumoral treatment
- Absolute neutrophil count > 1.5 x 109/l,
- Platelets > 100 x 109/l
- Total bilirubin < 1.5 × ULN,
- AST and ALT< 3 x ULN
- Effective contraception
- Negative pregnancy test (serum beta-HCG) in females of reproductive age
- Written informed consent
- Affiliation to a social security scheme
- 18 years of age or older
- Karnofsky's Index over 50
- Non-contrast lesion on MRI
- Histologically proven low grade brainstem glioma with 2 exceptions:
- formal contraindication to surgery determined via discussion of the case with
expert neurosurgeons during a national webmeeting (GLITRAD)
- negative brainstem biopsy These two exceptions 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, PET, 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 with an infiltrative but non-threatening
pattern, warranting antitumoral treatment
- Absolute neutrophil count > 1.5 x 109/l,
- Platelets > 100 x 109/l
- Total bilirubin < 1.5 × ULN,
- AST and ALT< 3 x ULN
- Effective contraception
- Negative pregnancy test (serum beta-HCG) in females of reproductive age
- Written informed consent
- Affiliation to a social security scheme
- 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 webmeeting and a
very detailed checkup looking for diagnostic pitfalls
- Contrast enhancement on MRI
- Clinico-radiological data favoring a more aggressive lesion, such as a high grade
glioma, even in the case of a "low grade glioma" diagnosis after biopsy, suggesting
histological under-grading
- Previous radiotherapy or chemotherapy for this lesion
- Contraindication to Temozolomide (Hypersensitivity to Temozolomide, dacarbazine or
severe myelosuppression)
- Contraindication to IRM (pacemaker, intraocular metallic foreign bodies,
intracranial metal clips, non-removable hearing aids, neurostimulation electrodes
...)
- Contraindication to IASOdopa® (hypersensitivity)
- Severe renal insufficiency
- Concomitant serious illness unbalanced that may interfere with follow-up
- History of malignancy within 5 years (excluding basal cell carcinoma or in situ
carcinoma of the cervix)
- Pregnancy or breastfeeding
- Predictable difficulty with follow-up
- Patient under legal protection measures