Surgery in Treating Patients With Neuroblastoma - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 2, 2009

Start Date ^ICMJE

December 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety and efficacy [ Designated as safety issue: Yes ]
Predictive factors of relapse and survival [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety and efficacy
Predictive factors of relapse and survival

Change History

Complete list of historical versions of study NCT00003122 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Surgery in Treating Patients With Neuroblastoma

Official Title ^ICMJE

Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

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.

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 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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Neuroblastoma

Intervention ^ICMJE

Procedure: surgical procedure

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

210

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene
Study: Histologically proven neuroblastoma
- Stage I
- Stage II with amplified N-myc
- Stage II without evaluation of N-myc
- Stage II with symptomatic spinal cord compression
- Stage III
No metastases diagnosed within 1 month of study

PATIENT CHARACTERISTICS:

Age:

20 and under

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy
No adjuvant chemotherapy planned

Endocrine therapy:

Prior use of steroids allowed

Radiotherapy:

Not specified

Surgery:

Not specified

Gender

Both

Ages

up to 20 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Austria, France, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00003122

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065880, SIOP-95-1, EU-96053

Study Sponsor ^ICMJE

Societe Internationale d'Oncologie Pediatrique

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Jean Marie Michon, MD

Institut Curie Hopital

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP