Overview

This trial is active, not recruiting.

Conditions long-term effects secondary to cancer therapy in children, neuroblastoma
Treatment clinical observation
Phase phase 2
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Primary purpose supportive care

Primary Outcomes

Measure
Safety and efficacy
time frame:

Secondary Outcomes

Measure
Predictive factors of relapse and survival
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).