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Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors
This study is ongoing, but not recruiting participants.
Sponsored by: Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278239
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Cancer-Related Problem/Condition
 Procedure: cognitive assessment
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
 Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Study of Outcome of Children Previously Enrolled in European Trials of Treatment for Primitive Neuroectodermal Tumour (PNET)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life (QOL) as measured by QOL questionnaire

Secondary Outcome Measures:
  • Quality of survival compared among children undergoing different treatments by Health Utilities Index

Study Start Date: June 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Surviving primitive neuroectodermal tumor (PNET) patients previously enrolled in International Pediatric Oncology Society (SIOP) 2 or 3 phase III treatment trials
  • Surviving PNET patients eligible for and treated according to PNET 3 protocol but not randomized
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278239

Locations
Ireland
Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
United Kingdom, England
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Royal London Hospital
London, England, United Kingdom, E1 1BB
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
United Kingdom, Scotland
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
United Kingdom, Wales
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Colin Kennedy Southampton General Hospital
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000454509, CCLG-CNS-2002-03, EU-20578
Study First Received: January 16, 2006
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00278239  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
quality of life
long-term effects secondary to cancer therapy in children
psychosocial effects/treatment
cognitive/functional effects
childhood supratentorial primitive neuroectodermal tumor

Study placed in the following topic categories:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
 Quality of Life
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
 Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009



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