Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182728
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2005-09-15
Brief Title:
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue
Status:
COMPLETED
Status Verified Date:
2024-09
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:
NRR
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells Giving radiation during surgery may be an effective treatment for breast cancer
PURPOSE This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer
PURPOSE This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of intraoperative partial breast radiotherapy prior to surgical resection in older women with low-risk early stage primary invasive ductal carcinoma of the breast Feasibility will be determined by the rate of goodexcellent cosmesis as measured by the Radiation Therapy Oncology Group RTOG cosmetic rating scale in patients treated with this regimen compared with that of patients treated with partial breast brachytherapy in clinical trial RTOG-9517
Determine the incidence of grade 3-4 toxicity of this regimen in these patients
Determine the rate of ipsilateral breast recurrence including recurrence within the tumor bed as compared to elsewhere in the breast in patients treated with this regimen
Secondary
Determine the radiation-induced activation of receptors and signal transduction pathways involved in radiation response in patients treated with this regimen
OUTLINE This is a non-randomized study
Patients undergo intraoperative lymphatic mapping and sentinel lymphadenectomy OR standard level I II axillary dissection to evaluate the lymph nodes followed by intraoperative breast ultrasonography to define the tumor target volume Patients then undergo intraoperative single-dose partial breast radiotherapy followed by segmental mastectomy ie lumpectomy of the tumor Patients with 1 or 2 tumor-involved surgical margins may undergo repeat segmental mastectomy Patients with 2 tumor-involved surgical margins undergo mastectomy Patients determined to have a tumor size 3 cm or an extensive intraductal component on final pathology evaluation undergo standard external beam radiotherapy after surgery
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 2 to 3 years
Primary
Determine the feasibility of intraoperative partial breast radiotherapy prior to surgical resection in older women with low-risk early stage primary invasive ductal carcinoma of the breast Feasibility will be determined by the rate of goodexcellent cosmesis as measured by the Radiation Therapy Oncology Group RTOG cosmetic rating scale in patients treated with this regimen compared with that of patients treated with partial breast brachytherapy in clinical trial RTOG-9517
Determine the incidence of grade 3-4 toxicity of this regimen in these patients
Determine the rate of ipsilateral breast recurrence including recurrence within the tumor bed as compared to elsewhere in the breast in patients treated with this regimen
Secondary
Determine the radiation-induced activation of receptors and signal transduction pathways involved in radiation response in patients treated with this regimen
OUTLINE This is a non-randomized study
Patients undergo intraoperative lymphatic mapping and sentinel lymphadenectomy OR standard level I II axillary dissection to evaluate the lymph nodes followed by intraoperative breast ultrasonography to define the tumor target volume Patients then undergo intraoperative single-dose partial breast radiotherapy followed by segmental mastectomy ie lumpectomy of the tumor Patients with 1 or 2 tumor-involved surgical margins may undergo repeat segmental mastectomy Patients with 2 tumor-involved surgical margins undergo mastectomy Patients determined to have a tumor size 3 cm or an extensive intraductal component on final pathology evaluation undergo standard external beam radiotherapy after surgery
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 2 to 3 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