Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or … (NCT05071001) | Clinical Trial Compass
CompletedNot Applicable
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
France92 participantsStarted 2021-03-19
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
scores obtained in FactCOG as a whole and in each subscale