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Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416559
First Posted: December 28, 2006
Last Update Posted: September 20, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma.

PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.


Condition Intervention Phase
Long-term Effects Secondary to Cancer Therapy in Children Neuroblastoma Other: clinical observation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Supportive Care
Official Title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and efficacy

Secondary Outcome Measures:
  • Predictive factors of relapse and survival

Estimated Enrollment: 140
Study Start Date: December 2004
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).

Secondary

  • Determine predictive factors of relapse and survival of patients with stage 1, 2A, or 2B neuroblastoma without NMA who have undergone surgery only.

OUTLINE: This is a nonrandomized, multicenter study.

Patients with stage 1 or 2 disease and no N-myc amplification (NMA) undergo observation comprising clinical evaluation, ultrasound or CT scan of the abdomen, and chest x-ray periodically for up to 5 years. All other patients undergo additional therapy and follow-up according to national standards. Patients who develop recurrent disease or disease progression may undergo surgical resection, preceded or followed by chemotherapy, according to national standards.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed neuroblastoma or ganglioneuroblastoma
  • Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria:

    • Stage 1
    • Stage 2A or 2B meeting 1 of the following criteria:

      • With or without N-myc amplification
      • No evaluation of NMA
      • Symptomatic spinal cord compression
    • Stage 3*
    • Dumbbell syndrome with clinical signs of spinal cord compression*
  • NOTE: *These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment
  • Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy
  • No metastases within 1 month of diagnosis

    • No skin metastases by clinical examination and MIBG scan
    • Normal liver by CT scan or ultrasonography
    • Normal chest X-ray (in case of nonthoracic primary site)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior steroids allowed
  • No prior chemotherapy
  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): NCT00416559


Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Bruno De Bernardi, MD Istituto Giannina Gaslini
OverallOfficial: Jean Marie Michon, MD Institut Curie
  More Information

ClinicalTrials.gov Identifier: NCT00416559     History of Changes
Other Study ID Numbers: CDR0000454574
CCLG-NB-1995-06
EU-20596
CCLG-94-01
First Submitted: December 27, 2006
First Posted: December 28, 2006
Last Update Posted: September 20, 2013
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
long-term effects secondary to cancer therapy in children
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional 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