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

NCT ID: NCT00416559

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

clinical observation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Cancer and Leukaemia Group

OTHER

Sponsor Role: lead

Principal Investigators

Bruno De Bernardi, MD

Role: STUDY_CHAIR

Istituto Giannina Gaslini

Jean Marie Michon, MD

Role:

Institut Curie

Other Identifiers

CCLG-NB-1995-06

Identifier Type: -

Identifier Source: secondary_id

EU-20596

Identifier Type: -

Identifier Source: secondary_id

CCLG-94-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000454574

Identifier Type: -

Identifier Source: org_study_id