Surgery in Treating Patients With Neuroblastoma

Societe Internationale d'Oncologie Pediatrique

Status and phase: Unknown; Phase 2

Conditions: Neuroblastoma

Treatments: Procedure: surgical procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00003122

SIOP-95-1

EU-96053

CDR0000065880

Details and patient eligibility

About

RATIONALE: Surgery may be an effective treatment for neuroblastoma.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.

Full description

OBJECTIVES:

• Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma without N-myc amplification (NMA).
• Describe predictive factors of relapse and survival for stages I and II neuroblastoma without NMA treated by surgery alone.

OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative evaluations are performed 30 days following surgery. Study patients with stage I (without N-myc amplification) tumors and trial patients with stage II tumors receive no further therapy.

Study patients (except stage I patients) receive surgery and/or chemotherapy according to other protocols as necessary for disease progression or relapse.

Patients are followed every 3 months for the first year, then every 4 and 6 months for the second and third year respectively, then yearly for 5 years.

PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study portion.

Enrollment: 210 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene

• Study: Histologically proven neuroblastoma

  • Stage I
  • Stage II with amplified N-myc
  • Stage II without evaluation of N-myc
  • Stage II with symptomatic spinal cord compression
  • Stage III

• No metastases diagnosed within 1 month of study

PATIENT CHARACTERISTICS:

Age:

• 20 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy
• No adjuvant chemotherapy planned

Endocrine therapy:

• Prior use of steroids allowed

Radiotherapy:

• Not specified

Surgery:

• Not specified