Clinical trial · Interventional
Long Term Neurotoxic Effects of Chemotherapy in Survivors of Bone and Soft Tissue Sarcomas. A Retrospective Study
NCT02309242CI-TRIAL-00018915unknownN/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)
The aim of the proposed project is to study the long-term impact of adjuvant systemic multi- agent chemotherapy (cisplatin, anthracyclines, vincristine, methotrexate, alkylating agents) in survivors (treated between 1992 and 2014 in UZ Leuven) of paediatric bone or soft tissue sarcomas on neurocognitive functioning.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma Tumor | Osteosarcoma | ALIAS | 0.90 |
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neuropsychological assessment, MRI | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Neuropsychological assessment, MRI
- description
- This is a cross-sectional mono-center study examining survivors who were exposed to chemotherapy for bone or soft tissue sarcomas in childhood. Survivors of bone or soft tissue sarcomas will be examined with neuropsychological tests, questionnaires and advanced MR imaging (Neuropsychological assessment, MRI). Results will be compared to a healthy control group matched for age and sex.
- interventionNames
- Behavioral: Neuropsychological assessment, MRI
Primary outcomes (1)
- measure
- Neuropsychological functioning
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion criteria: * Survivors of paediatric bone or soft tissue sarcomas, who were treated from 1992 onwards in the paediatric haematooncology department of UZLeuven according to one of the following treatment protocols. \*For soft tissue sarcomas: MMT 95, MMT 98, RMS2005 or NRST2005 \*For Ewing sarcoma: EICESS 92, Euro-Ewing 99 or Euro-Ewing 2008 \*For osteosarcoma: EORTC 80931 or Euramos1 protocols * There will be variability in treatment regimens, but the patient group will be clustered into four subgroups: * Cisplatin and anthracyclines * Cisplatin, anthracyclines and methotrexate * Alkylating agents * Alkylating agents and anthracyclines Exclusion criteria: * Mental retardation documented before treatment * Inability to perform the tests because of motor or sensory deficits * Epilepsy * Other cognitive disorders * Depression * Relapse * Parameningeal or intracranial sarcomas * Syndrome (e.g. Down) * Autologous stemcell transplantation * Head/neck/spinal radiotherapy or psychopharmaca
References
Publications (0)
Data not yet available
No reference posted for this study.