Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003122
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
1999-11-01
Brief Title:
Surgery in Treating Patients With Neuroblastoma
Sponsor:
Societe Internationale dOncologie Pediatrique
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A 2B Neuroblastoma
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This phase II trial is studying how well surgery works in treating patients with neuroblastoma
Detailed Description:
OBJECTIVES
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 andor 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 35 years At least 70 more patients will be accrued for the study portion
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 andor 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 35 years At least 70 more patients will be accrued for the study portion
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SIOP-95-1 | None | None | None |
| EU-96053 | None | None | None |