Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290654
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2006-02-09
Brief Title:
Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit further patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ
PURPOSE This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ
Detailed Description:
OBJECTIVES
Primary
Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite Radiation Therapy System
Secondary
Determine the early and late complication rates and cosmetic outcome in these patients after treatment
OUTLINE Patients undergo lumpectomy Patients with negative tumor margins no ink on tumor undergo placement of the MammoSite Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery
NOTE If positive margins are present the surgeon may elect to resect the positive margins and then insert a new MammoSite device if all other eligibility criteria are met
Beginning 2-5 days after placement of the MammoSite patients undergo brachytherapy through the MammoSite twice daily for 5 days a total of 10 fractions
After completion of study treatment patients are followed periodically for 5 years
Primary
Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite Radiation Therapy System
Secondary
Determine the early and late complication rates and cosmetic outcome in these patients after treatment
OUTLINE Patients undergo lumpectomy Patients with negative tumor margins no ink on tumor undergo placement of the MammoSite Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery
NOTE If positive margins are present the surgeon may elect to resect the positive margins and then insert a new MammoSite device if all other eligibility criteria are met
Beginning 2-5 days after placement of the MammoSite patients undergo brachytherapy through the MammoSite twice daily for 5 days a total of 10 fractions
After completion of study treatment patients are followed periodically for 5 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 |
|---|---|---|---|
| UMN-0211M35761 | OTHER | IRB University of Minnesota | None |