Clinical trial NCT00416559: Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
Official title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Long-term Effects Secondary to Cancer Therapy in Children
Neuroblastoma
Keywords: long-term effects secondary to cancer therapy in children
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-12-28
Enrollment: 140
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Safety and efficacy
Secondary outcomes:
measure: Predictive factors of relapse and survival
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Giannina Gaslini
name: Bruno De Bernardi, MD
role: STUDY_CHAIR
affiliation: Institut Curie
name: Jean Marie Michon, MD
References: