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

NCT00276731 | Unknown Phase 3

• 4 other identifiers: CDR0000454725CCLG-NB-1995-02EU-20595UKCCSG-ENSG-9
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 22

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.

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma; localized unresectable neuroblastoma; regional neuroblastoma

Interventions

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

vincristine sulfate DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (22)

Our Lady's Hospital for Sick Children

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; Etoposide; Vincristine; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics

Study Officials

• Ann Barrett

  University of Glasgow

  STUDY CHAIR

• S. J. Keith Holmes, DO

  St. George's Hospital

• Janice A. Kohler, MD, FRCP

  University Hospital Southampton NHS Foundation Trust

• Andrew David J. Pearson, MD, FRCP, DCh

  University of Newcastle Upon-Tyne

• Jack van Hoff, MD

  Yale University

• Robert P. Castleberry, MD

  University of Alabama at Birmingham

• Kevin Murray, MD

  Mercy Regional Cancer Center at Mercy Medical Center

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: March 1, 1995
• Last Updated: September 17, 2013

Record last verified: 2006-01

Locations

GB (21); IE (1)