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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416559
First received: December 27, 2006
Last updated: September 19, 2013
Last verified: May 2007
  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

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416559

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00416559     History of Changes
Other Study ID Numbers: CDR0000454574, CCLG-NB-1995-06, EU-20596, CCLG-94-01
Study First Received: December 27, 2006
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014