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NCT05071001Completed

Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
92 (actual)
First submitted
27 Sept 2021
Start date
19 Mar 2021
Primary completion date
2 Jul 2024
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Diseases
Sarcoma
NCT number
NCT05071001

What you commit to

  • Study type: Interventional
  • Participants enrolled: 92
  • From 19 Mar 2021 to the primary completion date, 2 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • For study OSE A and B
  • Non-French speaking patients
  • Pregnant and breastfeeding women
    • For study OSE- B only:
    • \- Patient deprived of his liberty by a judicial or administrative decision

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.