Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
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|ClinicalTrials.gov Identifier: NCT00416559|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : December 28, 2006
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Long-term Effects Secondary to Cancer Therapy in Children Neuroblastoma||Other: clinical observation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma|
|Study Start Date :||December 2004|
- Safety and efficacy
- Predictive factors of relapse and survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416559
|Study Chair:||Bruno De Bernardi, MD||Istituto Giannina Gaslini|
|OverallOfficial:||Jean Marie Michon, MD||Institut Curie|