Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Sponsor

Societe Internationale d'Oncologie Pediatrique (Other)

Overall Status

Completed

CT.gov ID

NCT00025428

Collaborator

Children's Cancer and Leukaemia Group (Other)

100

Enrollment

Locations

155

Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2000

Actual Study Completion Date :

Nov 1, 2013

Outcome Measures

Primary Outcome Measures

Event-free survival at 3 years []

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Anna Children's Hospital	Vienna		Austria	A-1090
2	Universitair Ziekenhuis Gent	Ghent		Belgium	B-9000
3	Odense University Hospital	Odense		Denmark	DK-5000
4	Centre Hospitalier Regional de Purpan	Toulouse		France	31026
5	Children's Hospital	Cologne		Germany	D-50924
6	Istituto Giannina Gaslini	Genoa		Italy	16148
7	Rikshospitalet University Hospital	Oslo		Norway	0027
8	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.	Lisboa		Portugal	1099-023 Codex
9	Hospital Universitario LA FE	Valencia		Spain	46009
10	Ostra Sjukhuset	Gothenburg		Sweden	41685
11	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	CH-1011
12	Southampton University Hospital NHS Trust	Southampton	England	United Kingdom	SO16 6YD