Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354835
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2006-07-19
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Randomized Study of Vincristine Dactinomycin and Cyclophosphamide VAC Versus VAC Alternating With Vincristine and Irinotecan VI for Patients With Intermediate-Risk Rhabdomyosarcoma RMS
Status:
COMPLETED
Status Verified Date:
2023-01
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 randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma Drugs used in chemotherapy such as vincristine sulfate dactinomycin cyclophosphamide and irinotecan hydrochloride 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 together with radiation therapy may kill more tumor cells It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma
Detailed Description:
PRIMARY OBJECTIVES
I To compare the early response rates failure-free survival FFS and survival of patients with intermediate-risk rhabdomyosarcoma RMS treated with surgery radiotherapy and vincristine vincristine sulfate dactinomycin and cyclophosphamide VAC or VAC alternating with vincristine irinotecan irinotecan hydrochloride VI
SECONDARY OBJECTIVES
I To compare FFS local control and survival of patients with intermediate-risk RMS treated with VAC and early week 4 radiotherapy vs delayed week 10 radiotherapy using data from Intergroup Rhabdomyosarcoma Study IRS-IV for historic comparison
II To compare the acute and late effects of VAC to VAC alternating with VI including the toxicity associated with concurrent VI and radiotherapy
III To compare the acute and late effects of VAC as delivered on this study to D9803 VAC
IV To correlate change in fludeoxyglucose F-18 positron emission tomography FDG-PET maximum standard uptake value SUVmax from week 1 to week 4 and 15 with FFS
V For VI treated patients to correlate patient UDP glucuronosyltransferase 1 family polypeptide A1 UGT1A1 genotype with VI toxicity VI To correlate cytochrome P450 family 2 subfamily B polypeptide 6 CYP2B6 cytochrome P450 family 2 subfamily C polypeptide 9 CYP2C9 and glutathione S-transferase alpha 1 GSTA1 genotypes with VAC toxicity
VII To prospectively evaluate and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers
VIII To assess the frequency of bladder dysfunction in patients with bladder prostate and pelvic sites of RMS 3-6 years after study enrollment
OUTLINE Patients are randomized to 1 of 2 treatment arms within 42 days of initial surgery or biopsy
ARM I VAC Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13 16 19-25 28 31-37 and 40 dactinomycin IV over 1-5 minutes on day 1 of weeks 1 4 13 16 19 22 25 28 31 34 37 and 40 and cyclophosphamide IV over 1 hour on day 1 of weeks 1 4 7 10 13 16 19 22 25 28 31 34 37 and 40
ARM II VACVI Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-1316 17 19 20 22-26 28 31-34 37 38 and 40 dactinomycin IV over 1-5 minutes on day 1 of weeks 113 22 28 34 and 40 cyclophosphamide IV over 1 hour on day 1 of weeks 110 13 22 28 34 and 40 and irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4 7 16 19 25 31 and 37
In both arms treatment continues in the absence of disease progression or unacceptable toxicity Patients in both arms also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4 except patients with alveolar RMS rendered group I by amputation OR patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression
NOTE Individualized local control plan that deviates from protocol-mandated radiotherapy allowed for patients 24 months of age
After completion of study treatment patients are followed up every 2-4 months for 4 years and then annually for 5-10 years
I To compare the early response rates failure-free survival FFS and survival of patients with intermediate-risk rhabdomyosarcoma RMS treated with surgery radiotherapy and vincristine vincristine sulfate dactinomycin and cyclophosphamide VAC or VAC alternating with vincristine irinotecan irinotecan hydrochloride VI
SECONDARY OBJECTIVES
I To compare FFS local control and survival of patients with intermediate-risk RMS treated with VAC and early week 4 radiotherapy vs delayed week 10 radiotherapy using data from Intergroup Rhabdomyosarcoma Study IRS-IV for historic comparison
II To compare the acute and late effects of VAC to VAC alternating with VI including the toxicity associated with concurrent VI and radiotherapy
III To compare the acute and late effects of VAC as delivered on this study to D9803 VAC
IV To correlate change in fludeoxyglucose F-18 positron emission tomography FDG-PET maximum standard uptake value SUVmax from week 1 to week 4 and 15 with FFS
V For VI treated patients to correlate patient UDP glucuronosyltransferase 1 family polypeptide A1 UGT1A1 genotype with VI toxicity VI To correlate cytochrome P450 family 2 subfamily B polypeptide 6 CYP2B6 cytochrome P450 family 2 subfamily C polypeptide 9 CYP2C9 and glutathione S-transferase alpha 1 GSTA1 genotypes with VAC toxicity
VII To prospectively evaluate and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers
VIII To assess the frequency of bladder dysfunction in patients with bladder prostate and pelvic sites of RMS 3-6 years after study enrollment
OUTLINE Patients are randomized to 1 of 2 treatment arms within 42 days of initial surgery or biopsy
ARM I VAC Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13 16 19-25 28 31-37 and 40 dactinomycin IV over 1-5 minutes on day 1 of weeks 1 4 13 16 19 22 25 28 31 34 37 and 40 and cyclophosphamide IV over 1 hour on day 1 of weeks 1 4 7 10 13 16 19 22 25 28 31 34 37 and 40
ARM II VACVI Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-1316 17 19 20 22-26 28 31-34 37 38 and 40 dactinomycin IV over 1-5 minutes on day 1 of weeks 113 22 28 34 and 40 cyclophosphamide IV over 1 hour on day 1 of weeks 110 13 22 28 34 and 40 and irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4 7 16 19 25 31 and 37
In both arms treatment continues in the absence of disease progression or unacceptable toxicity Patients in both arms also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4 except patients with alveolar RMS rendered group I by amputation OR patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression
NOTE Individualized local control plan that deviates from protocol-mandated radiotherapy allowed for patients 24 months of age
After completion of study treatment patients are followed up every 2-4 months for 4 years and then annually for 5-10 years
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-2009-00427 | REGISTRY | None | None |
| 07-497 | None | None | None |
| CDR0000487560 | None | None | None |
| COG-ARST0531 | None | None | None |
| ARST0531 | OTHER | None | None |
| ARST0531 | OTHER | None | None |
| U10CA180886 | NIH | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |