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

NCT ID: NCT05071001

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2024-07-02

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

MRI

Intervention Type: 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.

B

Group Type: EXPERIMENTAL

MRI

Intervention Type: 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.

Interventions

MRI

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

2020-A00919-30

Identifier Type: -

Identifier Source: org_study_id