Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
This trial is active, not recruiting.
|Conditions||long-term effects secondary to cancer therapy in children, neuroblastoma|
|Sponsor||Children's Cancer and Leukaemia Group|
|Start date||December 2004|
|Trial size||140 participants|
|Trial identifier||NCT00416559, CCLG-94-01, CCLG-NB-1995-06, CDR0000454574, EU-20596|
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.
|Primary purpose||supportive care|
Safety and efficacy
Predictive factors of relapse and survival
Male or female participants up to 20 years old.
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
|Official title||Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma|
|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.|
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