Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence (OSE)
February 3, 2026 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Villejuif, France, 94800
- Gustave Roussy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
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This assessment will be planned in the year after the consent signAll patients will have one brain MRI performed in Henri Mondor Hospital on a 3T MR unit (Skyra, Siemens, Erlangen). The procedure will include:
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Experimental: B
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This assessment will be planned in the year after the consent signAll patients will have one brain MRI performed in Henri Mondor Hospital on a 3T MR unit (Skyra, Siemens, Erlangen). The procedure will include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
scores obtained in FactCOG as a whole and in each subscale
Time Frame: 3 years
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2021
Primary Completion (Actual)
July 2, 2024
Study Completion (Actual)
July 2, 2024
Study Registration Dates
First Submitted
September 27, 2021
First Submitted That Met QC Criteria
September 27, 2021
First Posted (Actual)
October 7, 2021
Study Record Updates
Last Update Posted (Actual)
February 5, 2026
Last Update Submitted That Met QC Criteria
February 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A00919-30
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.