Back to resultsObservation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
Primary Purpose
Long-term Effects Secondary to Cancer Therapy in Children, Neuroblastoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
clinical observation
Sponsored by
About this trial
This is an interventional supportive care trial for Long-term Effects Secondary to Cancer Therapy in Children focused on measuring long-term effects secondary to cancer therapy in children, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma
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
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and efficacy
Secondary Outcome Measures
Predictive factors of relapse and survival
Full Information
NCT ID
NCT00416559
First Posted
December 27, 2006
Last Updated
September 19, 2013
Sponsor
Children's Cancer and Leukaemia Group
1. Study Identification
Unique Protocol Identification Number
NCT00416559
Brief Title
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
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Cancer and Leukaemia Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
clinical observation
Primary Outcome Measure Information:
Title
Safety and efficacy
Secondary Outcome Measure Information:
Title
Predictive factors of relapse and survival
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno De Bernardi, MD
Organizational Affiliation
Istituto Giannina Gaslini
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean Marie Michon, MD
Organizational Affiliation
Institut Curie
12. IPD Sharing Statement
Learn more about this trial
Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
We'll reach out to this number within 24 hrs