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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00003119
Registration number
NCT00003119
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
13/03/2017
Titles & IDs
Public title
Surgery in Treating Children With Neuroblastoma
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Scientific title
Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study
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Secondary ID [1]
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COG-P9641
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Secondary ID [2]
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P9641
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuroblastoma
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Treatment 1 - Asymptomatic - no immediate chemotherapy -
Experimental: Symptomatic - immediate chemotherapy -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone
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Assessment method [1]
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The primary objective is to estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone. Under the assumption that about 90% of the low risk 2A/2B patients will be asymptomatic, and 10% of these will be lost to follow up, the projected sample size will enable estimation of the survival rate with a standard error less than .03. This sample size will also provide sufficient power for the sequential monitoring plan (see below) for this subgroup of patients.
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Timepoint [1]
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically proven low-risk neuroblastoma (excluding ganglioneuroma)
* International Neuroblastoma Staging System (INSS) stage 1 in all patients
* INSS stage 2A or 2B in patients less than 365 days of age
* INSS stage 2A or 2B tumor with nonamplified MYCN with any Shimada histology in patients ages 1 to 20 years
* INSS stage 2A or 2B tumor with amplified MYCN with Shimada favorable histology in patients ages 1 to 20 years
* INSS stage 4S tumors with nonamplified MYCN, Shimada favorable histology, and a DNA index not equal to 1 in patients less than 365 days of age
* Immediate chemotherapy allowed prior to biopsy for patients with intradural extension and/or emergent paresis if biopsy performed within 96 hours
* Must have no abnormal organ function unless due to neuroblastoma
* Concurrent registration on companion biology study (protocol COG-ANBL00B1) or its successor
PATIENT CHARACTERISTICS:
Age:
* Under 21
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal
Renal:
* Creatinine less than 1.5 times normal
Cardiovascular:
* Shortening fraction greater than 27% by echocardiogram OR
* Ejection fraction greater than 47% by radionuclide angiogram
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* No prior hormonal therapy
Radiotherapy:
* No prior radiotherapy
Surgery:
* Prior surgery allowed
Other:
* No other prior therapy
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Minimum age
No limit
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Maximum age
21
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/1998
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2006
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Sample size
Target
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Accrual to date
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Final
968
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Brisbane
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Women's and Children's Hospital - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2031 - Randwick
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2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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3052 - Parkville
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Recruitment postcode(s) [6]
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
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Name
Children's Oncology Group
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
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Trial website
https://clinicaltrials.gov/study/NCT00003119
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Trial related presentations / publications
Meany HJ, Attiyeh EF, Naranjo A, et al.: Outcome analysis of non-high-risk neuroblastoma patients enrolled on Children's Oncology Group trials P9641 and A3961. [Abstract] J Clin Oncol 30 (Suppl 15): A-9533, 2012. Attiyeh EF, Mosse YP, Diskin S, et al.: Identification of genomic DNA signatures predicting relapse in low- and intermediate- risk neuroblastoma using a case control design and high-density SNP genotyping: a Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9500, 526s, 2007. Strother DR, London WB, Schmidt ML, Brodeur GM, Shimada H, Thorner P, Collins MH, Tagge E, Adkins S, Reynolds CP, Murray K, Lavey RS, Matthay KK, Castleberry R, Maris JM, Cohn SL. Outcome after surgery alone or with restricted use of chemotherapy for patients with low-risk neuroblastoma: results of Children's Oncology Group study P9641. J Clin Oncol. 2012 May 20;30(15):1842-8. doi: 10.1200/JCO.2011.37.9990. Epub 2012 Apr 23.
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Public notes
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Contacts
Principal investigator
Name
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Douglas R. Strother, MD
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Address
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Alberta Children's Hospital
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Strother DR, London WB, Schmidt ML, Brodeur GM, Sh...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00003119
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