- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03932981
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)
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Florence LAIGLE-DONADEY, MD
- Phone Number: 01 42 16 03 81
- Email: florence.laigle-donadey@aphp.fr
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- APHP - Groupe Hospitalier Pitié-Salpetrière
-
Contact:
- Florence LAIGLE-DONADEY, MD
- Phone Number: 01 42 16 03 81
- Email: florence.laigle-donadey@aphp.fr
-
Contact:
- Nabila ROUSSEAU
- Email: nabila.rousseau@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Temozolomide
Chemotherapy by temozolomide
|
Temozolomide at a monthly standard dose of 150-200 mg/m2/day at day 1 to day 5 for a duration of treatment of 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate based on best response (Complete Response (CR) and Partial Response (PR)) to Temozolomide according to RANO criteria.
Time Frame: Baseline, every month for up to 12 months from start of treatment
|
A patient will be considered to be in an objective response to Temozolomide if the best response is a complete or partial response defined according to the RANO criteria.
|
Baseline, every month for up to 12 months from start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 15 months or later, up to 48 months
|
15 months or later, up to 48 months
|
|
Histological pattern of adult brainstem gliomas
Time Frame: 15 months
|
Description of the histological pattern of adult brainstem gliomas
|
15 months
|
Molecular pattern of adult brainstem gliomas
Time Frame: 15 months
|
Description of the molecular pattern of adult brainstem gliomas
|
15 months
|
Radiological pattern of adult brainstem gliomas based on standard and multimodal MRI
Time Frame: 15 months
|
Description of the radiological pattern of adult brainstem gliomas
|
15 months
|
Metabolic pattern of adult brainstem gliomas based on 18F-DOPA PET CT at initial diagnosis and its change after treatment
Time Frame: 15 months
|
Description of the metabolic pattern of adult brainstem gliomas
|
15 months
|
Volumetric velocity of the tumor growth before treatment start from the initial MRI until the last MRI before beginning of the treatment, established with sagittal cube FLAIR sequences
Time Frame: Approximatively one month (before beginning of treatment)
|
Description of the volumetric growth of adult brainstem gliomas before treatment
|
Approximatively one month (before beginning of treatment)
|
Volumetric velocity of the tumor growth during treatment of chemotherapy, established with sagittal cube FLAIR sequences
Time Frame: 12 months
|
Description of the volumetric growth of adult brainstem gliomas before treatment
|
12 months
|
Volumetric velocity of the tumor growth after treatment of chemotherapy, established with sagittal cube FLAIR sequences
Time Frame: up to 48 months
|
Description of the volumetric growth of adult brainstem gliomas after treatment
|
up to 48 months
|
Overall Survival
Time Frame: 15 months or later, up to 48 months
|
15 months or later, up to 48 months
|
|
Total score of quality of life measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together) during treatment
Time Frame: Every 2 months up to 12 months
|
Every 2 months up to 12 months
|
|
15-month life quality as measured by total score of European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together)
Time Frame: At 15 months
|
At 15 months
|
|
Objective response rate based on best response (CR and PR) to Temozolomide according to RANO criteria combined with total score obtained on three scales (ataxia measured by the SARA scale, diet/swallowing measured by the FOIS scale and diplopia).
Time Frame: Baseline, every month for up to 12 months from start of treatment
|
A patient will be considered to be in an objective response to Temozolomide if the best response is a complete or partial response defined according to the RANO criteria and without degradation on the three scales or if the best response is stable according to RANO criteria with an improvement on one on the three scales without degradation of the two others. An improvement is defined as an improvement of total score obtained on one of the three scales without degradation of the two others. Stabilization is defined as obtaining the same total score on all three scales. Degradation is defined as degradation of total score on at least one of the scales (even if the score obtained on another scale is improved) |
Baseline, every month for up to 12 months from start of treatment
|
Tolerance to Temozolomide defined by the frequencies and grades of adverse events defined by the CTCAE v5.0 November 27, 2017
Time Frame: During chemotherapy and until 12 months
|
During chemotherapy and until 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Florence Florence, MD, APHP - Groupe Hospitalier Pitié-Salpetrière
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- P160954J
- 2018-002654-79 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Brainstem Glioma
-
Helsinki University Central HospitalTurku University Hospital; Oulu University Hospital; Kuopio University Hospital; Tampere University HospitalCompletedBrainstem GliomaFinland
-
Beijing Tiantan HospitalDuke UniversityUnknownGlioblastoma | High Grade Glioma | Glioma, Malignant | Glioma of BrainstemChina
-
Hoffmann-La RochePediatric Brain Tumor ConsortiumCompletedBrainstem GliomaUnited States
-
Dana-Farber Cancer InstituteCelgene; Secura Bio, Inc.TerminatedPediatric Cancer | Diffuse Intrinsic Pontine Glioma | Pediatric Brain Tumor | Diffuse Glioma | Pediatric Brainstem Glioma | Pediatric Brainstem Gliosarcoma, RecurrentUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
National Cancer Institute (NCI)WithdrawnAstrocytoma | Glioblastoma Multiforme | Ependymoma | PNET | Brainstem Glioma
-
Children's Hospital Medical Center, CincinnatiCompletedAuditory Brainstem ResponseUnited States
-
National Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
City of Hope Medical CenterCompletedRecurrent High Grade Glioma | Adult Anaplastic Astrocytoma | Adult Anaplastic Oligodendroglioma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Recurrent Adult Brain Tumor | Recurrent Grade III Glioma | Adult Brain Tumor | Recurrent Grade IV Glioma | Adult Anaplastic...United States
-
Eurofarma Laboratorios S.A.Centro de Immunologia Molecular, CubaCompletedDiffuse Intrinsic Brainstem GliomasBrazil, Cuba
Clinical Trials on Temozolomide
-
Guangzhou Medical UniversityUnknownSmall Cell Lung Cancer | Metastatic CarcinomaChina
-
Bradmer Pharmaceuticals Inc.Terminated
-
University of SouthamptonBristol-Myers SquibbRecruitingCancer of Esophagus | Adenocarcinoma - GEJUnited Kingdom
-
Novartis PharmaceuticalsCompletedGlioblastomaAustralia, Spain, Canada, United States
-
Activartis BiotechCompleted
-
Peking Union Medical College HospitalBeijing Tiantan Hospital; Tianjin Medical University General HospitalUnknownMalignant GliomasChina
-
Yunpeng LiuUnknownExtensive Stage Small Cell Lung CancerChina
-
Yong-Kil HongNational Cancer Center, Korea; Samsung Medical Center; Seoul St. Mary's Hospital and other collaboratorsCompletedGlioblastomaKorea, Republic of
-
Medical University of South CarolinaTerminatedGlioma | Astrocytoma | Brain Tumor | Glioblastoma MultiformeUnited States
-
Merck Sharp & Dohme LLCTerminatedBreast Neoplasm | Brain Neoplasm | Second Neoplasm