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Completed

NCT Number: NCT00025428

Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

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.

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Key information

Conditions

Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Anna Children's Hospital, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin

Drug

Cyclophosphamide

Drug

Doxorubicin hydrochloride

Drug

etoposide

Drug

vincristine sulfate

Drug

adjuvant therapy

Procedure

conventional surgery

Procedure

neoadjuvant therapy

Procedure

Primary outcomes

  1. Event-free survival at 3 years

Sponsors and collaborators

Lead sponsor

Societe Internationale d'Oncologie Pediatrique

Other

Collaborators

  • Children's Cancer and Leukaemia Group

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2013
First posted
Jan 27, 2003
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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