Surgery in Treating Patients With Neuroblastoma | Recruiting
Surgery in Treating Patients With Neuroblastoma

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Neuroblastoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT00003122
Primary Trial ID Number
Summary
RATIONALE: Surgery may be an effective treatment for neuroblastoma. PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.
Research Details
  • OBJECTIVES: - Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma without N-myc amplification (NMA). - Describe predictive factors of relapse and survival for stages I and II neuroblastoma without NMA treated by surgery alone. OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative evaluations are performed 30 days following surgery. Study patients with stage I (without N-myc amplification) tumors and trial patients with stage II tumors receive no further therapy. Study patients (except stage I patients) receive surgery and/or chemotherapy according to other protocols as necessary for disease progression or relapse. Patients are followed every 3 months for the first year, then every 4 and 6 months for the second and third year respectively, then yearly for 5 years. PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study portion.
Phase
Phase 2
Study Design
Primary Purpose: Treatment
Study Type
Interventional
Intervention
Procedure : surgical procedure
Intervention Type
See Interventions above
Primary Outcome Measures
  • Safety and efficacy; null; Predictive factors of relapse and survival; null
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
N/A - 20 Years
Who Can Participate
Patients
Number of Participants
210
Participant Inclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage
  • IIA and IIB neuroblastoma without amplification of the N-myc oncogene
  • - Study: Histologically proven neuroblastoma
  • - Stage I
  • - Stage II with amplified N-myc
  • - Stage II without evaluation of N-myc
  • - Stage II with symptomatic spinal cord compression
  • - Stage III
  • - No metastases diagnosed within 1 month of study
  • PATIENT CHARACTERISTICS:
  • Age:
  • - 20 and under
  • Performance status:
  • - Not specified
  • Life expectancy:
  • - Not specified
  • Hematopoietic:
  • - Not specified
  • Hepatic:
  • - Not specified
  • Renal:
  • - Not specified
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy:
  • - Not specified
  • Chemotherapy:
  • - No prior chemotherapy
  • - No adjuvant chemotherapy planned
  • Endocrine therapy:
  • - Prior use of steroids allowed
  • Radiotherapy:
  • - Not specified
  • Surgery:
  • - Not specified
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Addenbrooke's Hospital
Cambridge
England
CB2 2QQ
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
GSK Investigational Site
London
WC1N 3JH
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
Southampton General Hospital
Southampton
England
SO16 6YD
Site: 44
Sheffield
S10 2TH
Research Site
Sutton
Surrey
SM2 5PT
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Aberdeen Royal Infirmary
Aberdeen
Scotland
AB25 2ZN
GSK Investigational Site
Liverpool
L12 2AP
Royal Belfast Hospital for Sick Children
Belfast
Northern Ireland
BT12 6BE
Royal Hospital for Sick Children
Glasgow
Glasgow City
G3 8SJ
Newcastle General Hospital
Newcastle upon Tyne
NE4 6BE
Oxford Radcliffe Hospital
Oxford
England
0X3 9DU
Royal Hospital for Sick Children
Edinburgh
Scotland
EH9 1LF
Local Institution
Bristol
Avon
BS2 8BJ
Llandough Hospital
Llandough
Wales
CF64 2XX
University College of London Hospitals
London
England
WIT 3AA
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, France, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom
Scientific Title
Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000065880
Sponsor(s)
Societe Internationale d'Oncologie Pediatrique
Key Dates

Recruitment Start Date

Dec 1994

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

01 Nov 1999

Last Updated

23 Aug 2013