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

NCT05071001 | Completed

• 1 other identifier: 2020-A00919-30
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)

Outcome Measures

Primary Outcomes (1)

• scores obtained in FactCOG as a whole and in each subscale

  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

Study Arms (2)

A

EXPERIMENTAL

Procedure: MRI

B

EXPERIMENTAL

Procedure: MRI

Interventions

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: 1. a 3D-FLAIR imaging 2. a morphometric study based on a 3DT1 MPRAGE gradient echo sequence (TR / TI / TE = 2300/900 /2.9 ms) 3. 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). 4. An evaluation of neuronal dysfunction using MR Spectroscopy. Spectroscopic data will be collected using a 2D CSI laser with a short TE technique. 5. Magnetization transfer imaging providing information about integrity of membranes.

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Osteosarcoma; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: March 19, 2021
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

FR (1)