CompletedNot Applicable

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

France92 participantsStarted 2021-03-19

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

scores obtained in FactCOG as a whole and in each subscale

Timeframe: 3 years

Trial details

NCT IDNCT05071001

SponsorGustave Roussy, Cancer Campus, Grand Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-02

View on ClinicalTrials.gov More Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.