Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002995
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Actinomycin D and Vincristine With or Without Radiation Therapy for Newly Diagnosed Patients With Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma IRS-V Protocol
Status:
COMPLETED
Status Verified Date:
2014-02
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:
RATIONALE Drugs used in chemotherapy 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 It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma
PURPOSE Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma
PURPOSE Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma
Detailed Description:
OBJECTIVES
Determine the failure-free survival FFS rate in patients with newly diagnosed low-risk rhabdomyosarcoma of embryonal or botryoid subtype meeting criteria for group I after treatment with dactinomycin and vincristine with or without radiotherapy
Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin vincristine and cyclophosphamide with or without radiotherapy
Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements embryonal histiotype who receive one of the above treatments
Determine new molecular markers specific to embryonal and botryoid tumor histologies which are of diagnostic and prognostic significance in patients treated with these regimens
OUTLINE Patients are assigned to 1 of 2 groups depending on histology and site of disease
Group I favorable tumor site negative lymph nodes stage 1 clinical group I IIA or III orbit only node negative N0 OR unfavorable tumor site negative or unknown lymph nodes stage 2 clinical group I Patients receive vincristine IV over 1 minute weekly for 8 weeks and dactinomycin IV over 1 minute once every 3 weeks for 4 doses Treatment repeats every 12 weeks for 4 courses Radiotherapy is administered to patients with clinical group II or III disease on weeks 3-8
Group II favorable tumor site positive lymph nodes stage 1 clinical group III orbit only node positive N1 OR favorable tumor site except orbit any lymph nodes stage 1 clinical group III OR unfavorable tumor site stage 2 clinical group II OR unfavorable tumor site stage 3 clinical group I or II Patients receive vincristine and dactinomycin as in group I Patients also receive cyclophosphamide IV over 30-60 minutes and filgrastim G-CSF or sargramostim GM-CSF subcutaneously once daily beginning 24 hours after completion of chemotherapy and continuing for 10 days or until blood counts recover Radiotherapy is administered on weeks 3-8 12-17 or 28-33 if clinically indicated as in group I
Patients are followed every 3-4 months for 3 years 4 years after diagnosis every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 254 patients for group I will be accrued for this study within 6 years Approximately 12 patients per year will be accrued for group II
Determine the failure-free survival FFS rate in patients with newly diagnosed low-risk rhabdomyosarcoma of embryonal or botryoid subtype meeting criteria for group I after treatment with dactinomycin and vincristine with or without radiotherapy
Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin vincristine and cyclophosphamide with or without radiotherapy
Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements embryonal histiotype who receive one of the above treatments
Determine new molecular markers specific to embryonal and botryoid tumor histologies which are of diagnostic and prognostic significance in patients treated with these regimens
OUTLINE Patients are assigned to 1 of 2 groups depending on histology and site of disease
Group I favorable tumor site negative lymph nodes stage 1 clinical group I IIA or III orbit only node negative N0 OR unfavorable tumor site negative or unknown lymph nodes stage 2 clinical group I Patients receive vincristine IV over 1 minute weekly for 8 weeks and dactinomycin IV over 1 minute once every 3 weeks for 4 doses Treatment repeats every 12 weeks for 4 courses Radiotherapy is administered to patients with clinical group II or III disease on weeks 3-8
Group II favorable tumor site positive lymph nodes stage 1 clinical group III orbit only node positive N1 OR favorable tumor site except orbit any lymph nodes stage 1 clinical group III OR unfavorable tumor site stage 2 clinical group II OR unfavorable tumor site stage 3 clinical group I or II Patients receive vincristine and dactinomycin as in group I Patients also receive cyclophosphamide IV over 30-60 minutes and filgrastim G-CSF or sargramostim GM-CSF subcutaneously once daily beginning 24 hours after completion of chemotherapy and continuing for 10 days or until blood counts recover Radiotherapy is administered on weeks 3-8 12-17 or 28-33 if clinically indicated as in group I
Patients are followed every 3-4 months for 3 years 4 years after diagnosis every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 254 patients for group I will be accrued for this study within 6 years Approximately 12 patients per year will be accrued for group II
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 |
|---|---|---|---|
| CDR0000065542 | OTHER | Clinical Trialsgov | None |
| COG-D9602 | OTHER | None | None |
| CCG-D9602 | OTHER | None | None |
| POG-D9602 | OTHER | None | None |
| IRS-D9602 | OTHER | None | None |