Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002900
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
1999-11-01
Brief Title:
SWOG-9342 Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A STUDY OF THE LATE CARDIAC EFFECTS OF TWO DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENTS IN WOMEN WITH NODE NEGATIVE BREAST CANCER TREATED ON SWOG-8897
Status:
COMPLETED
Status Verified Date:
2015-10
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This clinical trial is studying the effect of chemotherapy on heart function in treating women who have breast cancer with negative axillary lymph nodes and who are undergoing treatment on the SWOG-8897 clinical trial
PURPOSE This clinical trial is studying the effect of chemotherapy on heart function in treating women who have breast cancer with negative axillary lymph nodes and who are undergoing treatment on the SWOG-8897 clinical trial
Detailed Description:
OBJECTIVES
Compare the frequency of subclinical congestive heart failure by measuring resting MUGA at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy with cyclophosphamide methotrexate and fluorouracil or cyclophosphamide doxorubicin and fluorouracil on protocol SWOG-8897
Estimate the frequency of late cardiac effects congestive heart failure cardiac ischemic events and clinical symptoms in these patients treated with these regimens
Monitor prospectively the incidence of annual cardiac events between the fifth and tenth year after randomization of these patients to these regimens
OUTLINE This is a multicenter study
The treating physician completes patient cardiovascular and routine history and physical examination questionnaires at baseline and yearly Patients undergo resting MUGA scans at 5-8 and 10-11 years after registration on protocol SWOG-8897 The first scan must be performed within 3 months prior to enrollment or within 1 month after registration on the current study and the second scan must be done in the tenth year of follow-up and within 3 months prior to enrollment or 1 month from the anniversary of registration on the current study
PROJECTED ACCRUAL A total of 420 patients will be accrued for this study After initial accrual is completed approximately 50 additional patients will be accrued at 10 years
Compare the frequency of subclinical congestive heart failure by measuring resting MUGA at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy with cyclophosphamide methotrexate and fluorouracil or cyclophosphamide doxorubicin and fluorouracil on protocol SWOG-8897
Estimate the frequency of late cardiac effects congestive heart failure cardiac ischemic events and clinical symptoms in these patients treated with these regimens
Monitor prospectively the incidence of annual cardiac events between the fifth and tenth year after randomization of these patients to these regimens
OUTLINE This is a multicenter study
The treating physician completes patient cardiovascular and routine history and physical examination questionnaires at baseline and yearly Patients undergo resting MUGA scans at 5-8 and 10-11 years after registration on protocol SWOG-8897 The first scan must be performed within 3 months prior to enrollment or within 1 month after registration on the current study and the second scan must be done in the tenth year of follow-up and within 3 months prior to enrollment or 1 month from the anniversary of registration on the current study
PROJECTED ACCRUAL A total of 420 patients will be accrued for this study After initial accrual is completed approximately 50 additional patients will be accrued at 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 |
|---|---|---|---|
| SWOG-9342 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |