Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
N/A
20 Years
Both
Neuroblastoma
Trial Information
Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Safety and efficacy
Safety Issue:
Yes
Principal Investigator
Jean Marie Michon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Curie
Authority:
Unspecified
Study ID:
CDR0000065880
NCT ID:
NCT00003122
Start Date:
December 1994
Completion Date:
Related Keywords:
- Neuroblastoma
- localized resectable neuroblastoma
- localized unresectable neuroblastoma
- Neuroblastoma
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