Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
NCT ID: NCT00416559
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2004-12-31
Brief Summary
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PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SUPPORTIVE_CARE
Interventions
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clinical observation
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Bruno De Bernardi, MD
Role: STUDY_CHAIR
Istituto Giannina Gaslini
Jean Marie Michon, MD
Role:
Institut Curie
Other Identifiers
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CCLG-NB-1995-06
Identifier Type: -
Identifier Source: secondary_id
EU-20596
Identifier Type: -
Identifier Source: secondary_id
CCLG-94-01
Identifier Type: -
Identifier Source: secondary_id
CDR0000454574
Identifier Type: -
Identifier Source: org_study_id