Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
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.
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Rates of good/excellent cosmesis as measured by the RTOG cosmetic rating scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Incidence of grade 3/4 toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Association of nuclear p53 expression in tumor and normal tissue before and after IORT [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Association of nuclear NFkB expression in tumor and normal tissue before and after IORT [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Association of phosphorylated EGFR, HER2, p44/42 MAPK, and Akt in breast tumors and normal tissue before and after IORT [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Ipsilateral breast recurrence (tumor bed recurrence versus elsewhere in breast [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Intraoperative Radiation Arm
Intraoperative radiation during surgery for tumor excision.
neoadjuvantRadiation: radiation therapy
- 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.
- Determine the rate of good/excellent cosmesis, as measured by the RTOG cosmetic rating scale, in patients treated with this regimen.
- Compare the cosmetic outcome in patients treated with this regimen 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.
- 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 (i.e., 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182728
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||David Olilla, MD||UNC Lineberger Comprehensive Cancer Center|