Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only

Children's Cancer and Leukaemia Group

Status and phase: Unknown; Phase 2

Conditions: Neuroblastoma; Long-term Effects Secondary to Cancer Therapy in Children

Treatments: Other: clinical observation

Study type: Interventional

Funder types: Other

Identifiers

NCT00416559

CCLG-94-01

CCLG-NB-1995-06

CDR0000454574

EU-20596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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