Clinical trial · Interventional
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
NCT05071001CI-TRIAL-00102507OSEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Procedure: MRI
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Procedure: MRI
Primary outcomes (1)
- measure
- scores obtained in FactCOG as a whole and in each subscale
- timeFrame
- 3 years
- description
- Primary analysis will be performed on all patients included in the study, including history of Ewing (treated without HDMTX) and osteosarcoma (treated with HDMTX). This population is the main analysis population of the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For study OSE A and B * Patients treated for a bone sarcoma: Ewing or osteosarcoma * Age under 19 years at initial diagnosis * Treated in the Pediatric Oncology Department of Gustave For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis * Treated with at least one course of HDMTX for osteosarcoma * Treated without HDMTX for Ewing sarcoma * Time interval between the end of treatment and inclusion \>10 y * Age \> 21 y at inclusion * Patients with informed consent signed * Patient under guardianship * Affiliated to French health insurance or beneficiary of the same or equivalent For study OSE- B only: * Treated with at least 8 courses of HDMTX for osteosarcoma * Treated without HDMTX for Ewing sarcoma * Patients with Ewing sarcoma will have to be matched with osteosarcoma patients according to age at the time of treatment, sex, and duration of follow-up * School level equivalent of at least the end of primary school Exclusion Criteria: For study OSE A and B * Brain radiotherapy * Previous relapse except those treated by local treatment without any chemotherapy * Second malignancy treated with chemotherapy * High dose chemotherapy with stem cell support * Non-French speaking patients * Pregnant and breastfeeding women For study OSE- B only: \- Patient deprived of his liberty by a judicial or administrative decision
References
Publications (0)
Data not yet available
No reference posted for this study.