Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
Recruitment status was Active, not recruiting
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.
Long-term Effects Secondary to Cancer Therapy in Children
Other: clinical observation
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Supportive Care
|Official Title:||Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma|
- Safety and efficacy
- Predictive factors of relapse and survival
|Study Start Date:||December 2004|
- Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416559
|Study Chair:||Bruno De Bernardi, MD||Istituto Giannina Gaslini|
|Investigator:||Jean Marie Michon, MD||Institut Curie|