Informations générales (source: ClinicalTrials.gov)

NCT05071001 Statut inconnu
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
Interventional
  • Tumeurs osseuses
  • Sarcome d'Ewing
  • Ostéosarcome
N/A
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mars 2021
avril 2025
13 septembre 2025
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

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY Brice Fresneau, Dr En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
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



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