Surgery in Treating Patients With Neuroblastoma

Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003122

Enrollment

210

Registered

2003-01-27

Start date

1994-12-31

Completion date

Unknown

Last updated

2013-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma, localized unresectable neuroblastoma

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREsurgical procedure

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

No minimum to 20 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Safety and efficacy	—
Predictive factors of relapse and survival	—

Countries

Austria, France, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026