Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors

NCT ID: NCT00278239

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-30

Brief Summary

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RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for patients with primitive neuroectodermal tumors.

PURPOSE: This phase III trial is studying quality of life in patients who have undergone previous treatment for primitive neuroectodermal tumors.

Detailed Description

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OBJECTIVES:

Primary

* Determine the quality of survival of patients in the UK and other European countries enrolled in previous International Society of Pediatric Oncology (SIOP) 2 or 3 phase III trials for treatment of pediatric primitive neuroectodermal tumors (PNET).
* Compare the quality of survival between children allocated to different treatments in these trials.

Secondary

* Determine the framework that will allow similar information to be collected across all participating countries in the PNET 4 trial that opened in autumn 2002.

OUTLINE: This is a cross-sectional, multicenter study.

Pediatric oncologists, teachers, patients ≥ 12 years old, and parents of children age 3-11 years old complete six questionnaires to assess the patients' motor and sensory function, cognition, behavior, emotion, educational provision and achievement, social integration, and the subjective experience of the patients and their families.

PROJECTED ACCRUAL: A total of 229 patients will be accrued for this study.

Conditions

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Brain and Central Nervous System Tumors Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Children Psychosocial Effects of Cancer and Its Treatment

Keywords

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long-term effects secondary to cancer therapy in children psychosocial effects of cancer and its treatment cognitive/functional effects childhood supratentorial primitive neuroectodermal tumor

Interventions

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cognitive assessment

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* No metastatic disease at time of allocation to treatment
* No current progressive disease

PATIENT CHARACTERISTICS:

* No patient deemed unsuitable for this study by treating clinician

PRIOR CONCURRENT THERAPY:

* Not specified
Minimum Eligible Age

3 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Cancer and Leukaemia Group

OTHER

Sponsor Role lead

Principal Investigators

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Colin Kennedy

Role: STUDY_CHAIR

University Hospital Southampton NHS Foundation Trust

Locations

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Our Lady's Hospital for Sick Children

Dublin, , Ireland

Site Status

Birmingham Children's Hospital

Birmingham, England, United Kingdom

Site Status

Institute of Child Health at University of Bristol

Bristol, England, United Kingdom

Site Status

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom

Site Status

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, England, United Kingdom

Site Status

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, United Kingdom

Site Status

Royal London Hospital

London, England, United Kingdom

Site Status

Great Ormond Street Hospital for Children NHS Trust

London, England, United Kingdom

Site Status

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, United Kingdom

Site Status

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, United Kingdom

Site Status

Queen's Medical Centre

Nottingham, England, United Kingdom

Site Status

Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Site Status

Children's Hospital - Sheffield

Sheffield, England, United Kingdom

Site Status

Southampton General Hospital

Southampton, England, United Kingdom

Site Status

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, United Kingdom

Site Status

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, United Kingdom

Site Status

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, United Kingdom

Site Status

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

Site Status

Royal Hospital for Sick Children

Glasgow, Scotland, United Kingdom

Site Status

Childrens Hospital for Wales

Cardiff, Wales, United Kingdom

Site Status

Countries

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Ireland United Kingdom

Other Identifiers

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CCLG-CNS-2002-03

Identifier Type: -

Identifier Source: secondary_id

EU-20578

Identifier Type: -

Identifier Source: secondary_id

CDR0000454509

Identifier Type: -

Identifier Source: org_study_id