All studies
RecruitingPHASE2, PHASE3INTERVENTIONAL

An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma

This research project is designed to improve how we diagnose and treat ependymoma in children and young adults up to 22 years old. Ependymoma is a type of brain or spinal cord tumour. The study will test new ways of diagnosing the condition and different treatment plans, including combinations of chemotherapy and radiotherapy. Patients will be grouped based on their age, tumour location, and how much of the tumour was removed during initial surgery. Each group will then try a specific treatment to see which ones work best. The ultimate goal is to find better treatments and improve the lives of young patients with ependymoma.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
Centre Leon Berard
Enrolment target
536
Start
02 Jun 2015
Estimated completion
01 Aug 2031

What is this study about?

This study is focused on children and young adults under 22 who have been diagnosed with a type of brain or spinal cord tumour called ependymoma. The main aim is to develop better ways to diagnose and treat this condition, and to understand more about its biology. By getting a clearer picture of each patient's situation, the researchers hope to offer more effective treatments tailored to their specific needs. This involves looking closely at scans and tumour samples to confirm the diagnosis and plan the best approach.

The research is split into different groups, or 'strata', based on factors like a patient's age, where the tumour is located, and whether all of it could be removed in the first surgery. Some groups will compare chemotherapy with just observation after radiotherapy, while others will test different chemotherapy combinations. Regardless of the group, all treatments are carefully considered and aim to improve the chances of a good outcome for the patient.

Ultimately, this program seeks to set new standards for care and improve the long-term health and well-being of young people with ependymoma. It's a big effort involving many experts working together to find the most effective and gentle ways to treat this challenging disease.

Key takeaways

  • This study aims to improve ependymoma diagnosis and treatment for children and young adults.
  • It uses different treatment approaches, including chemotherapy and radiotherapy.
  • Patients are grouped based on age, tumour location, and surgical results.
  • Expert teams will review scans and tumour samples.
  • Potential benefits include access to advanced treatments; risks will be discussed.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is open to children and young adults up to 22 years old who have recently been diagnosed with ependymoma. All patients will have their diagnosis confirmed by experts before joining. Girls who have started their periods must not be pregnant or breastfeeding, and they'll need to use effective birth control during and for six months after the study treatment. Similarly, boys who could father a child will also need to use effective birth control for the same period.

There are certain health requirements to be part of the study. You shouldn't have any serious health conditions that are not related to your ependymoma that would make chemotherapy unsafe. Your blood, liver, and kidney functions need to be healthy enough to receive the treatments, and you shouldn't have any active infections. Also, you must not have received previous radiation or chemotherapy for this condition, except for steroids.

Depending on whether all of your tumour was removed during the first surgery and your age, you might fit into one of the different study groups. For example, some groups are for patients aged over 12 months and under 22 years whose tumour was completely removed, while other groups are for those in the same age range but with some tumour remaining that couldn't be surgically removed.

Quick self-check
  • Are you under 22 years old and newly diagnosed with ependymoma?
  • Has your diagnosis of ependymoma been confirmed by an expert team?
  • Are you generally well enough to receive treatment, with no unrelated serious health issues or infections?
  • If female and post-menarchal, are you not pregnant or breastfeeding, and willing to use effective birth control?
  • If male and able to father children, are you willing to use effective birth control?
  • Have you not had previous radiotherapy or chemotherapy for this condition (except steroids)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, your images and tumour samples will first be reviewed by experts to confirm your diagnosis and help decide the best treatment path. This might also involve discussing another surgery if it's considered helpful. You'll then be placed into one of three different treatment groups based on your age and the results of your surgery. Each group involves specific treatments like chemotherapy (e.g., VEC, CDDP, HD-MTX, Valproate) and radiotherapy, which is a common cancer treatment using high-energy rays.

Depending on your group, you might receive a course of chemotherapy for about 16 weeks, alongside or followed by radiotherapy. For some, if a small part of the tumour remains after initial therapy, an additional small dose of radiotherapy might be given. You'll have regular hospital visits for these treatments and to monitor your health. The total duration of your participation will depend on the specific treatment plan, but it will involve ongoing assessments and follow-up care for a period after treatment ends.

Potential risks and benefits

Taking part in this study could offer several potential benefits, including receiving treatments that are at the forefront of research for ependymoma, and having your case closely monitored by a team of experts. The hope is that these new approaches will lead to better outcomes for patients. However, like all medical treatments, there are potential risks and side effects associated with chemotherapy and radiotherapy that will be fully explained by your medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (40)

  • Medical University of Graz-Department of Pediatrics and Adolescent Medicine
    Graz, Austria· Recruiting
  • CHR de la CITADELLE
    Liège, Belgium· Recruiting
  • University Hospital Brno
    Brno, Czechia· Recruiting
  • Aarhus University Hospital
    Aarhus, Denmark· Recruiting
  • CHRU STRASBOURG - Hôpital de Hautepierre
    Strasbourg, France· Recruiting
  • AP-HM - Hôpital d'Enfants de La Timone
    Marseille, France· Recruiting
  • CHU Dijon - Hôpital des Enfants
    Dijon, France· Recruiting
  • CHRU BESANCON - Hôpital Jean Minjoz
    Besançon, France· Recruiting
  • CHRU BREST - Hôpital Morvan
    Brest, France· Recruiting
  • CHU de Bordeaux-Hôpital des enfants Pellegrin
    Bordeaux, France· Recruiting
  • CHU de TOULOUSE - Hôpital des Enfants
    Toulouse, France· Recruiting
  • CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve
    Montpellier, France· Recruiting

+28 more sites — see the official record for the full list.

Common questions

What is ependymoma?

Ependymoma is a type of tumour that starts in the brain or spinal cord, most commonly affecting children and young adults.

What kind of treatments will be given in this study?

Treatments include different combinations of chemotherapy (medication to kill cancer cells) and radiotherapy (using high-energy rays to destroy cancer cells).

Will I automatically get a new treatment if I join?

You will be placed into a treatment group that is being studied. For some, this might be a new treatment, while for others, it might involve standard care that is being compared to a new approach.

How long will I be in the study?

The length of time you're in the study depends on your specific treatment plan, but it will involve treatment sessions and follow-up appointments over a period of time.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your future medical care.

How to find out more

Pierre LEBLOND, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "An International Clinical Program for the Diagnosis and Trea…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.