Clinical Trials /

Surgery in Treating Patients With Neuroblastoma

NCT00003122

Description:

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.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title:Surgery in Treating Patients With Neuroblastoma
  • Official Title:Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

Clinical Trial IDs

  • ORG STUDY ID: CDR0000065880
  • SECONDARY ID: SIOP-95-1
  • SECONDARY ID: EU-96053
  • NCT ID: NCT00003122

Trial Conditions

  • Neuroblastoma

Trial Interventions

DrugSynonymsArms

Trial Purpose

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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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

Maximum Eligible Age:20 Years
Minimum Eligible Age:N/A
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and efficacy
Time Frame:
Safety Issue:Yes
Description:

Secondary Outcome Measures

Trial Keywords

  • localized resectable neuroblastoma
  • localized unresectable neuroblastoma