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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00003119




Trial ID
NCT00003119
Ethics application status
Date submitted
1/11/1999
Date registered
26/01/2003
Date last updated
9/03/2017

Titles & IDs
Public title
Surgery in Treating Children With Neuroblastoma
Scientific title
Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study
Secondary ID [1] 0 0
COG-P9641
Secondary ID [2] 0 0
P9641
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim
Other interventions - sargramostim
Treatment: Drugs - carboplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Surgery - adjuvant therapy
Treatment: Surgery - conventional surgery
Treatment: Other - radiation therapy

Experimental: Treatment 1 - Asymptomatic - no immediate chemotherapy -

Experimental: Symptomatic - immediate chemotherapy -


Other interventions: filgrastim


Other interventions: sargramostim


Treatment: Drugs: carboplatin


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: doxorubicin hydrochloride


Treatment: Drugs: etoposide


Treatment: Surgery: adjuvant therapy


Treatment: Surgery: conventional surgery


Treatment: Other: radiation therapy


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Intervention code [4] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone - 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.
Timepoint [1] 0 0

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
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00003119
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.
Public notes

Contacts
Principal investigator
Name 0 0
Douglas R. Strother, MD
Address 0 0
Alberta Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries