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Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
vincristine sulfate
adjuvant therapy
conventional surgery
neoadjuvant therapy
Sponsored by
Societe Internationale d'Oncologie Pediatrique
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring localized unresectable neuroblastoma

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Anna Children's Hospital
  • Universitair Ziekenhuis Gent
  • Odense University Hospital
  • Centre Hospitalier Regional de Purpan
  • Children's Hospital
  • Istituto Giannina Gaslini
  • Rikshospitalet University Hospital
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
  • Hospital Universitario LA FE
  • Ostra Sjukhuset
  • Centre Hospitalier Universitaire Vaudois
  • Southampton University Hospital NHS Trust

Outcomes

Primary Outcome Measures

Event-free survival at 3 years

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
December 3, 2013
Sponsor
Societe Internationale d'Oncologie Pediatrique
Collaborators
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00025428
Brief Title
Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
Official Title
Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Societe Internationale d'Oncologie Pediatrique
Collaborators
Children's Cancer and Leukaemia Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
localized unresectable neuroblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Event-free survival at 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice A. Kohler, MD, FRCP
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
St. Anna Children's Hospital
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Centre Hospitalier Regional de Purpan
City
Toulouse
ZIP/Postal Code
31026
Country
France
Facility Name
Children's Hospital
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Istituto Giannina Gaslini
City
Genoa
ZIP/Postal Code
16148
Country
Italy
Facility Name
Rikshospitalet University Hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
City
Lisboa
ZIP/Postal Code
1099-023 Codex
Country
Portugal
Facility Name
Hospital Universitario LA FE
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Ostra Sjukhuset
City
Gothenburg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Southampton University Hospital NHS Trust
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

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Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

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