Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only - Full Text View

Sponsored by:	Children's Cancer and Leukaemia Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416559

Purpose

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	Intervention	Phase
Cancer-Related Problem/Condition Neuroblastoma	Procedure: observation	Phase II

MedlinePlus related topics: Cancer Neuroblastoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized
Official Title:	Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

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

Primary Outcome Measures:

Safety and efficacy

Secondary Outcome Measures:

Predictive factors of relapse and survival

Estimated Enrollment:	140
Study Start Date:	December 2004

Detailed Description:

OBJECTIVES:

Primary

Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).

Secondary

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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed neuroblastoma or ganglioneuroblastoma
Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria:
- Stage 1
- Stage 2A or 2B meeting 1 of the following criteria:
  - With or without N-myc amplification
  - No evaluation of NMA
  - Symptomatic spinal cord compression
- Stage 3*
- Dumbbell syndrome with clinical signs of spinal cord compression*
NOTE: *These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment
Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy
No metastases within 1 month of diagnosis
- No skin metastases by clinical examination and MIBG scan
- Normal liver by CT scan or ultrasonography
- Normal chest X-ray (in case of nonthoracic primary site)

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Prior steroids allowed
No prior chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416559

Sponsors and Collaborators

Children's Cancer and Leukaemia Group

Investigators

Study Chair:	Bruno De Bernardi, MD	Istituto Giannina Gaslini
Investigator:	Jean Marie Michon, MD	Institut Curie Hopital

More Information

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

Study ID Numbers:	CDR0000454574, CCLG-NB-1995-06, EU-20596, CCLG-94-01
Study First Received:	December 27, 2006
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00416559
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

long-term effects secondary to cancer therapy in children
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis

Neuroepithelioma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009