Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003801
Status:
COMPLETED
Last Update Posted:
2009-08-20
First Post:
1999-11-01
Brief Title:
Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Intergroup Rhabdomyosarcoma Study Group Late Effects After Treatment for Rhabdomyosarcoma
Status:
COMPLETED
Status Verified Date:
2000-02
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 Cancer treatment may have risks that affect health outcomes later It is not yet known what health outcomes may be related to previous treatment for rhabdomyosarcoma
PURPOSE Study to determine health outcomes in patients who have survived 5 years after receiving treatment for rhabdomyosarcoma on the Intergroup Rhabdomyosarcoma Study Group protocols
PURPOSE Study to determine health outcomes in patients who have survived 5 years after receiving treatment for rhabdomyosarcoma on the Intergroup Rhabdomyosarcoma Study Group protocols
Detailed Description:
OBJECTIVES I Determine the frequency of self reported health related outcomes in patients with rhabdomyosarcoma who survived 5 years from diagnosis after treatment on Intergroup Rhabdomyosarcoma Study Group IRSG protocols I II III and IV pilot II Determine the mortality of these patients and compare this mortality to the general population especially in the third and fourth decades of life III Determine treatment specific risks of developing a second malignancy following treatment of rhabdomyosarcoma and the potential genetic influences family history of cancer IV Determine the association between decreased fertilityoffspring and dose schedule and total dose of alkylating agents especially cyclophosphamide received during treatment and with selected genitourinary and paratesticular primaries V Determine the effect of the dose and location of therapeutic radiation for primary head and neck cancer on achieved final height VI Determine the association of therapy with doxorubicin dose and age when received with cardiac and vascular events
OUTLINE Patients or parent or surviving family member complete the baseline questionnaire plus other questionnaires offspring family history other topic specific Medical data is also collected from past records
PROJECTED ACCRUAL Approximately 1600 patients will be accrued for this study
OUTLINE Patients or parent or surviving family member complete the baseline questionnaire plus other questionnaires offspring family history other topic specific Medical data is also collected from past records
PROJECTED ACCRUAL Approximately 1600 patients will be accrued for this study
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 |
|---|---|---|---|
| POG-D9801 | None | None | None |
| IRS-D9801 | None | None | None |
| CCG-D9801 | None | None | None |