NCT00278239

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
Last Updated

September 20, 2013

Status Verified

April 1, 2006

First QC Date

January 16, 2006

Last Update Submit

September 19, 2013

Conditions

Keywords

long-term effects secondary to cancer therapy in childrenpsychosocial effects of cancer and its treatmentcognitive/functional effectschildhood supratentorial primitive neuroectodermal tumor

Outcome Measures

Primary Outcomes (1)

  • Quality of life (QOL) as measured by QOL questionnaire

Secondary Outcomes (1)

  • Quality of survival compared among children undergoing different treatments by Health Utilities Index

Interventions

Eligibility Criteria

Age3 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (21)

Our Lady's Hospital for Sick Children

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Mental Status and Dementia TestsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesRehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Colin Kennedy

    University Hospital Southampton NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

June 1, 2002

Last Updated

September 20, 2013

Record last verified: 2006-04

Locations