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Surgery in Treating Children With Neuroblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003119
First Posted: January 27, 2003
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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.


Condition Intervention Phase
Neuroblastoma Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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.


Enrollment: 968
Study Start Date: March 1998
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1 - Asymptomatic - no immediate chemotherapy Procedure: conventional surgery Radiation: radiation therapy
Experimental: Symptomatic - immediate chemotherapy Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003119


  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Douglas R. Strother, MD Alberta Children's Hospital
  More Information

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.

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003119     History of Changes
Other Study ID Numbers: P9641
COG-P9641 ( Other Identifier: Children's Oncology Group )
POG-P9641 ( Other Identifier: Pediatric Oncology Group )
CCG-P9641 ( Other Identifier: Children's Cancer Group )
CDR0000065874 ( Other Identifier: Clinical Trials.gov )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Children's Oncology Group:
localized resectable neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Liposomal doxorubicin
Carboplatin
Doxorubicin
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic