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

NCT00416559 | Unknown Phase 2

• 4 other identifiers: CDR0000454574CCLG-NB-1995-06EU-20596CCLG-94-01
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy

Secondary Outcomes (1)

• Predictive factors of relapse and survival

Interventions

clinical observation OTHER

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

MeSH Terms

Conditions

Neuroblastoma

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Bruno De Bernardi, MD

  Istituto Giannina Gaslini

  STUDY CHAIR

• Jean Marie Michon, MD

  Institut Curie

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: December 1, 2004
• Last Updated: September 20, 2013

Record last verified: 2007-05