Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245141
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2005-10-25
Brief Title:
Vincristine Dactinomycin and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Sponsor:
Japan Rhabdomyosarcoma Study Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Short VAC12 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
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 dactinomycin and cyclophosphamide 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 more than one drug combination chemotherapy with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving vincristine dactinomycin and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma
PURPOSE This phase II trial is studying how well giving vincristine dactinomycin and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma
Detailed Description:
OBJECTIVES
Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine dactinomycin and cyclophosphamide with or without radiotherapy
OUTLINE Patients receive vincristine IV dactinomycin IV and cyclophosphamide IV Patients may also undergo radiotherapy Treatment repeats every 3 weeks for up to 8 courses total of 24 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study
Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine dactinomycin and cyclophosphamide with or without radiotherapy
OUTLINE Patients receive vincristine IV dactinomycin IV and cyclophosphamide IV Patients may also undergo radiotherapy Treatment repeats every 3 weeks for up to 8 courses total of 24 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 32 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 |
|---|---|---|---|
| CDR0000453316 | REGISTRY | PDQ Physician Data Query | None |