Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

Active, not recruiting

• Conditions: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Long-term Effects Secondary to Cancer Therapy in Children; Ototoxicity

• Registration Number: NCT00683319
• Lead Sponsor: Children's Cancer and Leukaemia Group

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-23
• Status Verified: 2009-06
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20
• Primary Completion: 2034-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival
Event-free survival
Response to chemotherapy, if there is residual disease
Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)
Late effects of treatment (i.e., ototoxicity and nephrotoxicity at the completion of chemotherapy and neurocognitive outcomes at 5, 7, 11, and 16 years of age)

Trial Locations

Locations (10)

Royal Manchester Children's Hospital; 🇬🇧 Manchester, England, United Kingdom

Great Ormond Street Hospital for Children; 🇬🇧 London, England, United Kingdom

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

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