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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Study of Outcome of Children Previously Enrolled in European Trials of Treatment for Primitive Neuroectodermal Tumour (PNET)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00278239
• Other study ID #: CDR0000454509
• Secondary ID: CCLG-CNS-2002-03
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 16, 2006
• Last updated: September 19, 2013
• Start date: June 2002

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 24 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

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

Intervention

Procedure:
• cognitive assessment

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children	Dublin
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Institute of Child Health at University of Bristol	Bristol	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	Childrens Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England
United Kingdom	Great Ormond Street Hospital for Children NHS Trust	London	England
United Kingdom	Royal London Hospital	London	England
United Kingdom	Central Manchester and Manchester Children's University Hospitals NHS Trust	Manchester	England
United Kingdom	Sir James Spence Institute of Child Health	Newcastle-Upon-Tyne	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Children's Hospital - Sheffield	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QOL) as measured by QOL questionnaire
Secondary	Quality of survival compared among children undergoing different treatments by Health Utilities Index