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| ID | Type | Description | Link |
|---|---|---|---|
| CCLG-1992-05 | |||
| EU-20593 | |||
| CCLG-9205 |
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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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, the tumor may not need any treatment until it progresses. In this case, observation may be sufficient.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with surgery and radiation therapy works in treating infants with neuroblastoma.
OBJECTIVES:
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 4 treatment groups according to disease stage.
NOTE: * OJEC chemotherapy with a lower dose of carboplatin
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| cyclophosphamide | Drug | |||
| etoposide | Drug | |||
| vincristine sulfate | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed newly diagnosed neuroblastoma
Must be able to start treatment before reaching 13 months of age
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Penelope Brock, MD, PhD | University College London Hospitals | Study Chair |
| Mary P. Gerrard, MBChB, FRCP, FRCPCH | Children's Hospital - Sheffield | |
| Andrew David J. Pearson, MD, FRCP, DCh | University of Newcastle Upon-Tyne | |
| S. J. Keith Holmes, DO | St. George's Hospital | |
| Ann Barrett | University of Glasgow |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children | Dublin | 12 | Ireland | |||
| Birmingham Children's Hospital |
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| Procedure |
| radiation therapy | Radiation |
| Birmingham |
| England |
| B4 6NH |
| United Kingdom |
| Institute of Child Health at University of Bristol | Bristol | England | BS2 8AE | United Kingdom |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | CB2 2QQ | United Kingdom |
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool Children's Hospital, Alder Hey | Liverpool | England | L12 2AP | United Kingdom |
| Royal London Hospital | London | England | E1 1BB | United Kingdom |
| Great Ormond Street Hospital for Children NHS Trust | London | England | WC1N 3JH | United Kingdom |
| Meyerstein Institute of Oncology at University College of London Hospitals | London | England | WIT 3AA | United Kingdom |
| Central Manchester and Manchester Children's University Hospitals NHS Trust | Manchester | England | M27 4HA | United Kingdom |
| Sir James Spence Institute of Child Health | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
| Queen's Medical Centre | Nottingham | England | NG7 2UH | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 9DU | United Kingdom |
| Children's Hospital - Sheffield | Sheffield | England | S10 2TH | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Royal Marsden NHS Foundation Trust - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
| Royal Aberdeen Children's Hospital | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | Scotland | EH9 1LF | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | Scotland | G3 8SJ | United Kingdom |
| Childrens Hospital for Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D014750 | Vincristine |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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