Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00416559
• Other study ID #: CDR0000454574
• Secondary ID: CCLG-NB-1995-06E
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 27, 2006
• Last updated: September 19, 2013
• Start date: December 2004

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Long-term Effects Secondary to Cancer Therapy in Children
• Neuroblastoma

Intervention

Other:
• clinical observation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy
Secondary	Predictive factors of relapse and survival