Clinical trial • Phase IV • Oncology
Carboplatin for Adult medulloblastoma | Medulloblastoma
Phase IV trial of Carboplatin for Adult medulloblastoma | Medulloblastoma. None/Not specified-controlled. 45 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Adult medulloblastoma | Medulloblastoma
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 02-05-2024
- First CTIS Authorization Date
- 24-05-2024
Trial design
None/Not specified-controlled Phase IV trial across 7 sites in France.
- Comparator
- None/Not specified
- Target Sample Size
- 45
Eligibility
Recruits 45 The trial did not select a vulnerable population; participants are adults. No assent/consent handling details are provided in the record..
- Vulnerable Population
- The trial did not select a vulnerable population; participants are adults. No assent/consent handling details are provided in the record.
Recruitment
- Planned Sample Size
- 45
- Recruitment Window Months
- 163
- Consent Approach
- Informed consent process not detailed in the record; participants are adults and no assent or language-specific consent information is provided.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 45
France
- Earliest CTIS Part Ii Submission Date
- 15-05-2024
- Latest Decision Or Authorization Date
- 24-05-2024
- Processing Time Days
- 9
- Number Of Sites
- 7
- Number Of Participants
- 45
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Oncologie
- Contact Person Name
- Mathieu BOONE
- Contact Person Email
- boone.mathieu@yahoo.fr
- Site Name
- Centre Leon Berard
- Department Name
- Radiothérapie
- Contact Person Name
- Marie-Pierre SUNYACH
- Contact Person Email
- Marie-Pierre.Sunyach@lyon.unicancer.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Radiothérapie
- Contact Person Name
- Marie CHARISSOUX
- Contact Person Email
- Marie.Charissoux@icm.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Neurochirurgie
- Contact Person Name
- Apolline MONTFILLIETTE DEJLAD
- Contact Person Email
- Apolline.DJELAD@CHRU-LILLE.FR
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neurologie
- Contact Person Name
- Florence LAIGLE-DONADEY
- Contact Person Email
- florence.laigle-donadey@psl.aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Neuro-Oncologie
- Contact Person Name
- Maryline Barrié
- Contact Person Email
- maryline.barrie@aphm.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Radiothérapie
- Contact Person Name
- Anne LAPRIE
- Contact Person Email
- Laprie.Anne@iuct-oncopole.fr
Sponsor
Primary sponsor
- Full Name
- CHRU De Nancy
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Carboplatin
- Active Substance
- Carboplatin
- Modality
- Small molecule
- Investigational Product Name
- Etoposide
- Active Substance
- Etoposide
- Modality
- Small molecule
- Combination Treatment
- Yes
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