Clinical trial NCT00278239: Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors
Official title: Study of Outcome of Children Previously Enrolled in European Trials of Treatment for Primitive Neuroectodermal Tumour (PNET)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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: long-term effects secondary to cancer therapy in children
psychosocial effects of cancer and its treatment
cognitive/functional effects
childhood supratentorial primitive neuroectodermal tumor
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-18
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief 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.

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 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

Primary outcomes:
measure: Quality of life (QOL) as measured by QOL questionnaire
Secondary outcomes:
measure: Quality of survival compared among children undergoing different treatments by Health Utilities Index
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospital for Sick Children
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: England
city: Bristol
country: United Kingdom
facility: Institute of Child Health at University of Bristol
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Children's Hospital, Alder Hey
state: England
city: London
country: United Kingdom
facility: Royal London Hospital
state: England
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Trust
state: England
city: Manchester
country: United Kingdom
facility: Central Manchester and Manchester Children's University Hospitals NHS Trust
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Sir James Spence Institute of Child Health
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Children's Hospital - Sheffield
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust - Surrey
state: England
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Royal Aberdeen Children's Hospital
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Cardiff
country: United Kingdom
facility: Childrens Hospital for Wales
state: Wales
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Colin Kennedy
role: STUDY_CHAIR
References: