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

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Medical Conditions
  • Neuroblastoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Recruiting
Trial source and source ID number
NCT00003122

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Southampton General Hospital
Southampton
England
SO16 6YD
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Aberdeen Royal Infirmary
Aberdeen
Scotland
AB25 2ZN
Nottingham
NG7 2UH
Cambridge
CB2 2QQ
Bristol Royal Hospital for Children
Bristol
England
BS2 8BJ
London
WC1N 3JH
Oxford Radcliffe Hospital
Oxford
England
0X3 9DU
Site GB46
Liverpool
L12 2AP
Newcastle General Hospital
Newcastle upon Tyne
England
NE4 6BE
University of Glasgow
Glasgow
G3 8SJ
Middlesex Hospital- Meyerstein Institute
London
England
WIT 3AA
GB006
Sheffield
S10 2TH
Royal Belfast Hospital for Sick Children
Belfast
Northern Ireland
BT12 6BE
Royal Hospital for Sick Children
Edinburgh
Scotland
EH9 1LF
University Hospital Llandough
Llandough
CF64 2XX
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

01 Nov 1999

Date updated in source

23 Aug 2013