Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416676
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2006-12-27
Brief Title:
Combination Chemotherapy and Surgery With or Without Radiation Therapy in Treating Patients With Stage 2 or Stage 3 Neuroblastoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
UKCCSG Stage IIB3 INSS Neuroblastoma Pilot Study ENSG VI Pilot 2B3
Status:
UNKNOWN
Status Verified Date:
2006-12
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 such as vincristine cyclophosphamide cisplatin etoposide and carboplatin 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 combination chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase III trial is studying how well giving combination chemotherapy and surgery with or without radiation therapy works in treating patients with stage 2 or stage 3 neuroblastoma
PURPOSE This phase III trial is studying how well giving combination chemotherapy and surgery with or without radiation therapy works in treating patients with stage 2 or stage 3 neuroblastoma
Detailed Description:
OBJECTIVES
Determine the acute and late toxicity of local radiotherapy when given after vincristine cisplatin etoposide and cyclophosphamide OPEC alternating with vincristine carboplatin etoposide and cyclophosphamide OJEC chemotherapy and surgery and followed by further chemotherapy in patients with stage 2B or 3 neuroblastoma
Determine the response in patients treated with alternating OPEC and OJEC chemotherapy before and after surgery
Determine the local control and event-free and overall survival of patients who achieve a complete response after chemotherapy and surgery alone
Determine the local control and event-free and overall survival of patients who do not achieve a complete response after chemotherapy and surgery and subsequently receive local radiotherapy
Determine clinical and biological prognostic factors for patients with stage 2B or 3 neuroblastoma when treated with this approach
OUTLINE This is a pilot multicenter study
Patients receive OPEC chemotherapy comprising vincristine IV and cyclophosphamide IV on day 1 cisplatin IV continuously over 24 hours on day 1 and etoposide IV over 4 hours on day 3 during courses 1 3 and 5 Patients receive OJEC chemotherapy comprising vincristine IV cyclophosphamide IV etoposide IV over 4 hours and carboplatin IV over 1 hour on day 1 during courses 2 and 4 Treatment repeats every 21 days for 5 courses After 5 courses patients with resectable disease undergo surgical resection Patients who achieve a complete response CR either after surgery or after 5 courses of chemotherapy alone where surgery is not possible receive 2 additional courses of chemotherapy OPEC followed by OJEC Patients who do not achieve a CR undergo radiotherapy for 3 weeks During the first week of radiotherapy these patients also receive vincristine IV on day 1 and etoposide IV over 4 hours on days 1 and 2 Beginning 3 weeks after the completion of radiotherapy these patients receive 2 additional courses of chemotherapy OPEC followed by OJEC
After completion of study treatment patients are followed periodically for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine the acute and late toxicity of local radiotherapy when given after vincristine cisplatin etoposide and cyclophosphamide OPEC alternating with vincristine carboplatin etoposide and cyclophosphamide OJEC chemotherapy and surgery and followed by further chemotherapy in patients with stage 2B or 3 neuroblastoma
Determine the response in patients treated with alternating OPEC and OJEC chemotherapy before and after surgery
Determine the local control and event-free and overall survival of patients who achieve a complete response after chemotherapy and surgery alone
Determine the local control and event-free and overall survival of patients who do not achieve a complete response after chemotherapy and surgery and subsequently receive local radiotherapy
Determine clinical and biological prognostic factors for patients with stage 2B or 3 neuroblastoma when treated with this approach
OUTLINE This is a pilot multicenter study
Patients receive OPEC chemotherapy comprising vincristine IV and cyclophosphamide IV on day 1 cisplatin IV continuously over 24 hours on day 1 and etoposide IV over 4 hours on day 3 during courses 1 3 and 5 Patients receive OJEC chemotherapy comprising vincristine IV cyclophosphamide IV etoposide IV over 4 hours and carboplatin IV over 1 hour on day 1 during courses 2 and 4 Treatment repeats every 21 days for 5 courses After 5 courses patients with resectable disease undergo surgical resection Patients who achieve a complete response CR either after surgery or after 5 courses of chemotherapy alone where surgery is not possible receive 2 additional courses of chemotherapy OPEC followed by OJEC Patients who do not achieve a CR undergo radiotherapy for 3 weeks During the first week of radiotherapy these patients also receive vincristine IV on day 1 and etoposide IV over 4 hours on days 1 and 2 Beginning 3 weeks after the completion of radiotherapy these patients receive 2 additional courses of chemotherapy OPEC followed by OJEC
After completion of study treatment patients are followed periodically for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| EU-20594 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000454571 | REGISTRY | None | None |