Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

Glioma Clinical Trial

— GlioUnder5  

Official title:

Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03690570
• Other study ID #: 6964
• Status: Recruiting
• Start date: May 9, 2018
• Est. completion date: May 9, 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Strasbourg, France
• Contact: Natacha ENTZ-WERLE, MD, PhD
• Phone: 33.3.88.12.80.96
• Email: Natacha.Entz-Werle[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• Children under 5 years old

• High grade glioma (WHO status III or IV)

• No previous treatment with chemotherapy or radiotherapy

• No contraindication to chemotherapy

• Consent of legal representative for participation in the study

Exclusion Criteria:

• Low grade glioma

• Any other histological pattern

• Parent's denial to access data concerning their child in the frame of medical research

Related Conditions & MeSH terms

• Glioma

Locations

Country	Name	City	State
France	Service de Pédiatrie 3	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of patient survival associated with relapse rate after surgery		10 years
Primary	Assessment of patient survival associated with relapse rate after chemotherapy		10 years