Long-term Effects Secondary to Cancer Therapy in Children, Neuroblastoma
Conditions
Keywords
long-term effects secondary to cancer therapy in children, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma
Brief 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.
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.
Interventions
OTHERclinical observation
Sponsors
Children's Cancer and Leukaemia Group
Study design
Allocation
NON_RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
No minimum to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Predictive factors of relapse and survival | — |
Outcome results
None listed