Surgery in Treating Patients With Neuroblastoma - Full Text View

Sponsor:	Societe Internationale d'Oncologie Pediatrique
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003122

Purpose

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	Intervention	Phase
Neuroblastoma	Procedure: surgical procedure	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

Resource links provided by NLM:

MedlinePlus related topics: Neuroblastoma Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Estimated Enrollment:	210
Study Start Date:	December 1994

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.

Eligibility

Ages Eligible for Study:	up to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003122

Show 96 Study Locations

Sponsors and Collaborators

Societe Internationale d'Oncologie Pediatrique

Investigators

Study Chair:

Jean Marie Michon, MD

Institut Curie

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000065880, SIOP-95-1, EU-96053
Study First Received:	November 1, 1999
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00003122 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

localized resectable neuroblastoma
localized unresectable neuroblastoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 18, 2010