Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-29 @ 2:40 PM
Study NCT ID:
NCT00003404
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Study Overview
Official Title:
A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
Status:
COMPLETED
Status Verified Date:
2018-12
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:
PURPOSE: This phase II trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.
Detailed Description:
OBJECTIVES:
* Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
* Determine the survival rate in patients treated with this regimen.
METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.
* Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
* Determine the survival rate in patients treated with this regimen.
METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA023108 | NIH | None | https://reporter.nih.gov/quic… | View |
| DMS-9801 | None | None | View | |
| DMS-12752 | None | None | View | |
| NCI-V98-1442 | None | None | View |