Spots Global Cancer Trial Database for 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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Trial Identification
Brief Title: Combination Chemotherapy Followed By Surgery With or Without Radiation Therapy in Treating Young Patients With Stage II or Stage III Neuroblastoma
Official Title: Randomized Study of Radiotherapy in Patients With Stage 2B/3 (INSS) Neuroblastoma in Children Over 1 Year of Age
Study ID: NCT00276731
Conditions
Study Description
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.
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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Our Lady's Hospital for Sick Children, Dublin, , Ireland
Birmingham Children's Hospital, Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol, Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey, Liverpool, England, United Kingdom
Royal London Hospital, London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust, London, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust, Manchester, England, United Kingdom
Sir James Spence Institute of Child Health, Newcastle-Upon-Tyne, England, United Kingdom
Queen's Medical Centre, Nottingham, England, United Kingdom
Oxford Radcliffe Hospital, Oxford, England, United Kingdom
Children's Hospital - Sheffield, Sheffield, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital, Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom
Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales, Cardiff, Wales, United Kingdom
Contact Details
Name: Ann Barrett
Affiliation: University of Glasgow
Role: STUDY_CHAIR
Name: S. J. Keith Holmes, DO
Affiliation: St. George's Hospital
Role:
Name: Janice A. Kohler, MD, FRCP
Affiliation: University Hospital Southampton NHS Foundation Trust
Role:
Name: Andrew David J. Pearson, MD, FRCP, DCh
Affiliation: University of Newcastle Upon-Tyne
Role:
Name: Jack van Hoff, MD
Affiliation: Yale University
Role:
Name: Robert P. Castleberry, MD
Affiliation: University of Alabama at Birmingham
Role:
Name: Kevin Murray, MD
Affiliation: Mercy Regional Cancer Center at Mercy Medical Center
Role:
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