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

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

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Key information

Conditions

Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma) Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Sarcoma Sarcoma, Ewing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy

Villejuif, 94800, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Procedure

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:

a 3D-FLAIR imaging
a morphometric study based on a 3DT1 MPRAGE gradient echo sequence (TR / TI / TE = 2300/900 /2.9 ms)
an analysis of the anatomic connectivity of the patient's brain assessed using a 1.5mm isotopic DTI with a high number of directions (HARDI / 65 directions / b=1500s/mm2).
An evaluation of neuronal dysfunction using MR Spectroscopy. Spectroscopic data will be collected using a 2D CSI laser with a short TE technique.
Magnetization transfer imaging providing information about integrity of membranes.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: OSE

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Oct 7, 2021
Registry last updated: Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed