Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
N/A
20 Years
Both
Long-term Effects Secondary to Cancer Therapy in Children, Neuroblastoma
Trial Information
Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Safety and efficacy
Principal Investigator
Bruno De Bernardi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Istituto Giannina Gaslini
Authority:
United States: Federal Government
Study ID:
CDR0000454574
NCT ID:
NCT00416559
Start Date:
December 2004
Completion Date:
Related Keywords:
- Long-term Effects Secondary to Cancer Therapy in Children
- Neuroblastoma
- long-term effects secondary to cancer therapy in children
- localized resectable neuroblastoma
- localized unresectable neuroblastoma
- regional neuroblastoma
- Neuroblastoma
Name | Location |
|---|
