Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278109
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2006-01-16
Brief Title:
Partial Breast Irradiation With Chemotherapy
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase III Partial Breast Irradiation With Concurrent Chemotherapy
Status:
COMPLETED
Status Verified Date:
2019-03
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 Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy such as cyclophosphamide and doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain
PURPOSE This phase III trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery
PURPOSE This phase III trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery
Detailed Description:
OBJECTIVES
Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation PBI and concurrent cyclophosphamidedoxorubicin AC chemotherapy
Assess the cosmetic effects of partial breast irradiationchemotherapy PBIC in these patients
Assess the local control rate in patients treated with this regimen
OUTLINE Patients undergo partial breast radiotherapy once daily 5 days a week for 3 weeks Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for approximately 10 years
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation PBI and concurrent cyclophosphamidedoxorubicin AC chemotherapy
Assess the cosmetic effects of partial breast irradiationchemotherapy PBIC in these patients
Assess the local control rate in patients treated with this regimen
OUTLINE Patients undergo partial breast radiotherapy once daily 5 days a week for 3 weeks Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for approximately 10 years
PROJECTED ACCRUAL A total of 42 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 |
|---|---|---|---|
| 04-03-22-01 | OTHER | JHM IRB | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| CDR0000446085 | None | None | None |