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


Phase 3
3 Years
24 Years
Open (Enrolling)
Both
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

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Quality of life (QOL) as measured by QOL questionnaire

Principal Investigator

Colin Kennedy

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Southampton NHS Foundation Trust.

Authority:

United States: Federal Government

Study ID:

CDR0000454509

NCT ID:

NCT00278239

Start Date:

June 2002

Completion Date:

Related Keywords:

  • 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
  • long-term effects secondary to cancer therapy in children
  • psychosocial effects of cancer and its treatment
  • cognitive/functional effects
  • childhood supratentorial primitive neuroectodermal tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

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