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

Not Applicable

Recruiting

• Conditions: Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)
• Interventions: Procedure: MRI

• Registration Number: NCT05071001
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-19
• Status Verified: 2021-09
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Study First Posted: 2021-10-07
• Last Update Posted: 2021-10-07
• Primary Completion: 2025-04-07
• Study Completion: 2025-04-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 530

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	MRI	-
A	MRI	-

Primary Outcome Measures

Name	Time	Method
scores obtained in FactCOG as a whole and in each subscale	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.

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France