Status:
COMPLETED
Intraoperative Radiotherapy for Early Stage Breast Cancer
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Breast Cancer
Eligibility:
FEMALE
48+ years
Phase:
NA
Brief Summary
Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanc...
Detailed Description
Patients will be deemed eligible for immediate IORT if the invasive cancer lesion is estimated to measure ≤ 3.0 centimeters maximum dimension by mammogram, ultrasound, and CE-MRI and is thought to be ...
Eligibility Criteria
Inclusion
- Informed Consent. Each eligible patient must willingly give written consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
- Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast.
- Female, age ≥ 48 years.
- Clinically and/or histologically negative axillary lymph nodes.
- No imaging or clinical findings that indicate metastatic disease.
- Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist.
Exclusion
- Male sex
- Age \< 48
- Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer
- Pregnancy or lactation
- Serious psychiatric or addictive disorders
- More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI.
- Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist.
- Ipsilateral breast with a previous cancer and/or irradiation.
- Extensive Intraductal Component (DCIS ≥ 25% of the tumor).
- Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled.
- Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
- Lymphovascular invasion on needle biopsy.
- Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01189851
Start Date
June 1 2010
End Date
December 1 2023
Last Update
October 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hoag Memorial Hospital Presbyterian - Cancer Center
Newport Beach, California, United States, 92658