Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075582
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2004-01-09
Brief Title:
Vincristine Dactinomycin and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Vincristine Dactinomycin and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk EmbryonalBotryoidSpindle Cell Rhabdomyosarcoma
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
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:
This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma Drugs used in chemotherapy such as vincristine dactinomycin and cyclophosphamide work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine V dactinomycin A cyclophosphamide C and radiotherapy
SECONDARY OBJECTIVES
I Determine local control rates in patients treated with this regimen II Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis clinical group III and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor
III Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection
OUTLINE This is a nonrandomized multicenter study Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group
REGIMEN I subset 1 patients closed to accrual as of 08132010 Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1 4 7 and 10 VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13 16 19 and 22 and radiotherapy 5 days a week beginning on week 13 and continuing for 4-7 weeks depending on prescribed dose
REGIMEN II subset 2 patientsclosed to accrual as of 9232011 Patients receive VAC chemotherapy and radiotherapy as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 25-33 and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13 16 19 22 25 28 31 34 37 40 43 and 46 Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy and continued VA chemotherapy In both regimens treatment continues in the absence of disease progression or unacceptable toxicity
NOTE For both regimens dactinomycin is omitted during radiotherapy
NOTE Clinical Group I tumors and those with Clinical Group III uterinecervix primary disease with negative nodes who have undergone a complete resection ie hysterectomy at Week 13 do not receive radiotherapy at Week 13
Patients are followed up every 3 months for 1 year every 4 months for 2 years every 6 months for 1 year and then annually thereafter
I Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine V dactinomycin A cyclophosphamide C and radiotherapy
SECONDARY OBJECTIVES
I Determine local control rates in patients treated with this regimen II Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis clinical group III and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor
III Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection
OUTLINE This is a nonrandomized multicenter study Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group
REGIMEN I subset 1 patients closed to accrual as of 08132010 Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1 4 7 and 10 VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13 16 19 and 22 and radiotherapy 5 days a week beginning on week 13 and continuing for 4-7 weeks depending on prescribed dose
REGIMEN II subset 2 patientsclosed to accrual as of 9232011 Patients receive VAC chemotherapy and radiotherapy as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 25-33 and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13 16 19 22 25 28 31 34 37 40 43 and 46 Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy and continued VA chemotherapy In both regimens treatment continues in the absence of disease progression or unacceptable toxicity
NOTE For both regimens dactinomycin is omitted during radiotherapy
NOTE Clinical Group I tumors and those with Clinical Group III uterinecervix primary disease with negative nodes who have undergone a complete resection ie hysterectomy at Week 13 do not receive radiotherapy at Week 13
Patients are followed up every 3 months for 1 year every 4 months for 2 years every 6 months for 1 year and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00425 | REGISTRY | None | None |
| COG-ARST0331 | OTHER | None | None |
| CDR0000347078 | OTHER | None | None |
| U10CA098543 | NIH | Clinical Trialsgov | httpsreporternihgovquickSearchU10CA098543 |