Status:
UNKNOWN
Long Term Neurotoxic Effects of Chemotherapy in Survivors of Bone and Soft Tissue Sarcomas. A Retrospective Study
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Sarcoma, Soft Tissue
Osteosarcoma Tumor
Eligibility:
All Genders
7-25 years
Phase:
NA
Brief Summary
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 (...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02309242
Start Date
December 1 2014
End Date
October 1 2018
Last Update
August 21 2015
Active Locations (1)
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1
UZ Leuven , pediatric oncology
Leuven, Vl Brabant, Belgium, 3000