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CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday
RATIONALE: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help doctors plan better treatment. PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard combination chemotherapy.
OBJECTIVES: Primary * To determine the overall survival and event-free survival of all infants diagnosed with ependymoma before their third birthday. * To determine the overall survival and event-free survival of infants diagnosed with ependymoma before their third birthday when treated with standard chemotherapy comprising vincristine, carboplatin, high-dose methotrexate, cyclophosphamide, and cisplatin. Secondary * To investigate the reasons why the primary tumor was completely resected in patients who were able to undergo complete resection of the tumor. * To continue to investigate the biological characteristics of ependymoma. * To correlate functional imaging studies of ependymoma with biological characteristics of the tumor. * To provide a standard treatment regimen for patients with residual disease after optimal surgery who have already participated in a phase II study. * To prospectively document renal function, hearing, and neurocognitive late effects after completion of study treatment. OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection and presence of metastatic disease (complete resection of tumor vs metastatic disease at diagnosis vs no complete resection of tumor). Patients receive vincristine IV on days 1, 15, and 29, carboplatin IV over 1 hour on day 1, high-dose methotrexate\* IV over 24 hours on day 15, cyclophosphamide IV over 1 hour on day 29, and cisplatin IV over 48 hours on days 43 and 44. Treatment repeats every 8 weeks for 7 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease after completion of treatment may receive other treatment at the discretion of the investigator. NOTE: \*Patients initially treated on clinical trial CCLG-CNS-2005-03 who have no residual disease do not receive high-dose methotrexate in courses 5-7. Patients undergo observational assessments comprising physical and neurological examination; MRI/ MRS scanning of the head and spine; and audiology, renal, endocrine, neurocognitive, and quality of life evaluations periodically for at least 5 years after the completion of study treatment.
Age
0 - 2 years
Sex
ALL
Healthy Volunteers
No
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Start Date
April 1, 2008
Primary Completion Date
March 1, 2034
Last Updated
September 20, 2013
50
ESTIMATED participants
carboplatin
DRUG
cisplatin
DRUG
cyclophosphamide
DRUG
methotrexate
DRUG
vincristine sulfate
DRUG
adjuvant therapy
PROCEDURE
cognitive assessment
PROCEDURE
magnetic resonance imaging
PROCEDURE
magnetic resonance spectroscopic imaging
PROCEDURE
quality-of-life assessment
PROCEDURE
Lead Sponsor
Children's Cancer and Leukaemia Group
NCT00602667
NCT00819208
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07416188