Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276731
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2006-01-12
Brief Title:
Combination Chemotherapy Followed By Surgery With or Without Radiation Therapy in Treating Young Patients With Stage II or Stage III Neuroblastoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Study of Radiotherapy in Patients With Stage 2B3 INSS Neuroblastoma in Children Over 1 Year of Age
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UKCCSG-ENSG-9 | None | None | None |
| CCLG-NB-1995-02 | None | None | None |
| EU-20595 | None | None | None |