Surgery in Treating Patients With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00003122|
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : January 27, 2003
Last Update Posted : August 26, 2013
RATIONALE: Surgery may be an effective treatment for neuroblastoma.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Procedure: surgical procedure||Phase 2|
- Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma without N-myc amplification (NMA).
- Describe predictive factors of relapse and survival for stages I and II neuroblastoma without NMA treated by surgery alone.
OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative evaluations are performed 30 days following surgery. Study patients with stage I (without N-myc amplification) tumors and trial patients with stage II tumors receive no further therapy.
Study patients (except stage I patients) receive surgery and/or chemotherapy according to other protocols as necessary for disease progression or relapse.
Patients are followed every 3 months for the first year, then every 4 and 6 months for the second and third year respectively, then yearly for 5 years.
PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study portion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Official Title:||Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma|
|Study Start Date :||December 1994|
- Safety and efficacy
- Predictive factors of relapse and survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003122
Show 96 Study Locations
|Study Chair:||Jean Marie Michon, MD||Institut Curie|