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Combination Chemotherapy Followed By Surgery With or Without Radiation Therapy in Treating Young Patients With Stage II or Stage III Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00276731
Recruitment Status : Unknown
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2006
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain. It is not yet know whether combination chemotherapy followed by surgery alone is more effective than combination chemotherapy followed by surgery and radiation therapy in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by surgery to see how well it works compared to combination chemotherapy followed by surgery and radiation therapy in treating young patients with stage II or stage III neuroblastoma.


Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the local control and event-free and overall survival of young patients with stage IIB and III neuroblastoma treated with neoadjuvant combination chemotherapy followed by surgery with vs without radiotherapy.
  • Determine the toxic effects of these regimen in these patients.

OUTLINE: This is a multicenter, randomized study.

  • Induction combination chemotherapy: Patients receive vincristine IV and cyclophosphamide IV on day 1. Patients also receive cisplatin IV continuously over 24 hours on day 1 and etoposide IV over 4 hours on day 2 during courses 1, 3, and 5 and carboplatin IV over 1 hour and etoposide IV over 4 hours on day 1 during courses 2 and 4. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to surgery unless complete resection was done during initial staging and complete response was maintained.
  • Surgery: Patients undergo biopsy or surgical resection of the tumor 2-3 weeks after completion of induction combination chemotherapy.
  • Post-surgical treatment: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive two additional courses of combination chemotherapy comprising vincristine, cisplatin, etoposide, and cyclophosphamide in course 6 and vincristine, carboplatin, etoposide, and cyclophosphamide in course 7.
    • Arm II: Patients undergo radiotherapy 2-4 weeks after surgery. Beginning 3 weeks after completion of radiotherapy, patients receive chemotherapy as in arm I After completion of study treatment, patients are evaluated periodically.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.


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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Study of Radiotherapy in Patients With Stage 2B/3 (INSS) Neuroblastoma in Children Over 1 Year of Age
Study Start Date : March 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma





Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IIB or III neuroblastoma

    • No n-myc amplification

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276731


Locations
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Ireland
Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Royal London Hospital
London, England, United Kingdom, E1 1BB
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
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Study Chair: Ann Barrett University of Glasgow
OverallOfficial: S. J. Keith Holmes, DO St. George's Hospital
OverallOfficial: Janice A. Kohler, MD, FRCP University Hospital Southampton NHS Foundation Trust
OverallOfficial: Andrew David J. Pearson, MD, FRCP, DCh University of Newcastle Upon-Tyne
OverallOfficial: Jack van Hoff, MD Yale University
OverallOfficial: Robert P. Castleberry, MD University of Alabama at Birmingham
OverallOfficial: Kevin Murray, MD Mercy Regional Cancer Center at Mercy Medical Center

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ClinicalTrials.gov Identifier: NCT00276731     History of Changes
Other Study ID Numbers: CDR0000454725
CCLG-NB-1995-02
EU-20595
UKCCSG-ENSG-9
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: January 2006

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma

Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Carboplatin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators