Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025428
• Other study ID #: CDR0000068960
• Secondary ID: SIOP-NB-2009CCLG
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2001
• Last updated: December 3, 2013
• Start date: December 2000
• Est. completion date: November 2013

Study information

• Verified date: November 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.

Description:

OBJECTIVES:

• Determine the outcome, in terms of local control, event-free survival, and overall survival, of children with localized unresectable neuroblastoma without MYCN amplification treated with carboplatin, etoposide, cyclophosphamide, doxorubicin, and vincristine followed by surgery.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3 (courses 1 and 3). Patients receive cyclophosphamide IV over 1 hour on days 1-5 (or orally on days 2 and 3), doxorubicin IV over 6 hours on days 4-5, and vincristine IV on days 1 and 5 (courses 2 and 4). Treatment repeats every 21 days for 4 courses. Patients then undergo surgical resection followed by 2 additional courses of chemotherapy.

Patients are followed at months 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, and 60.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of localized unresectable neuroblastoma

• Stage II or III

• No MYCN amplification

PATIENT CHARACTERISTICS:

Age:

• Over 1

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

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• carboplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• vincristine sulfate

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
Austria	St. Anna Children's Hospital	Vienna
Belgium	Universitair Ziekenhuis Gent	Ghent
Denmark	Odense University Hospital	Odense
France	Centre Hospitalier Regional de Purpan	Toulouse
Germany	Children's Hospital	Cologne
Italy	Istituto Giannina Gaslini	Genoa
Norway	Rikshospitalet University Hospital	Oslo
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.	Lisboa
Spain	Hospital Universitario LA FE	Valencia
Sweden	Ostra Sjukhuset	Gothenburg
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Southampton University Hospital NHS Trust	Southampton	England

Sponsors (2)

Lead Sponsor	Collaborator
Societe Internationale d'Oncologie Pediatrique	Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Italy,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival at 3 years			No