Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278239
First received: January 16, 2006
Last updated: August 19, 2009
Last verified: April 2006
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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 Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Children Psychosocial Effects of Cancer and Its Treatment |
Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Observational |
| Official Title: | Study of Outcome of Children Previously Enrolled in European Trials of Treatment for Primitive Neuroectodermal Tumour (PNET) |
Resource links provided by NLM:
Genetics Home Reference related topics:
Ewing sarcoma
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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 |
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 | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Institute of Child Health at University of Bristol | |
| Bristol, England, United Kingdom, BS2 8AE | |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Great Ormond Street Hospital for Children NHS Trust | |
| London, England, United Kingdom, WC1N 3JH | |
| Royal London Hospital | |
| London, England, United Kingdom, E1 1BB | |
| Central Manchester and Manchester Children's University Hospitals NHS Trust | |
| Manchester, England, United Kingdom, M27 4HA | |
| Sir James Spence Institute of Child Health | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden NHS Foundation Trust - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Royal Aberdeen Children's Hospital | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Childrens Hospital for Wales | |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
| Study Chair: | Colin Kennedy | University Hospital Southampton NHS Foundation Trust. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00278239 History of Changes |
| Other Study ID Numbers: | CDR0000454509, CCLG-CNS-2002-03, EU-20578 |
| Study First Received: | January 16, 2006 |
| Last Updated: | August 19, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
long-term effects secondary to cancer therapy in children psychosocial effects of cancer and its treatment cognitive/functional effects childhood supratentorial primitive neuroectodermal tumor |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms by Site Neoplasms |
Nervous System Diseases Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 23, 2013