Study on Ultra-Hypofractionated Radiation with Lumpectomy Boost for Stage I-III Breast Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT06954831
This clinical trial is exploring a new radiation treatment method for patients with stage I-III breast cancer. The study aims to see if a shorter, more intense radiation schedule, combined with a boost to the surgery site, can effectively prevent cancer from returning and improve patients' quality of life.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is testing a new way to deliver radiation therapy for patients with stage I-III breast cancer. Traditionally, radiation is given daily over 5-6 weeks, but this trial uses a method called ultra-hypofractionated whole breast irradiation (UF-WBI) with a lumpectomy cavity boost (CB), which delivers higher doses over just 5 days. This approach aims to kill more cancer cells, reduce side effects, and make treatment more convenient. The goal is to see if this method can prevent cancer from coming back and improve survival and quality of life for patients.
Description
The main goal of this study is to see how the new radiation treatment affects the appearance of the breast one year after treatment, as reported by patients. Other goals include evaluating the short- and long-term cosmetic effects, side effects from radiation, and the chances of cancer returning or spreading over five years. Researchers will also look at how the treatment affects patients' quality of life and other factors related to breast appearance and radiation side effects.
Participants will receive the new radiation treatment once a day for five days, with each session including a special scan to guide the radiation. After finishing the treatment, patients will have follow-up visits at 1 month, 6 months, and then once a year for up to 5 years to monitor their health and the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Must be 40 years or older.
- Female patients only.
- Must be able to read and understand English for completing questionnaires.
- Must have a confirmed diagnosis of breast cancer that is epithelial in nature.
- Must have had breast-conserving surgery, with re-excision allowed for clear margins.
- Must have had surgical staging of the lymph nodes.
- Must have at least one high-risk feature that requires a boost to the lumpectomy site.
- Must have a good or excellent cosmetic outcome after surgery, as judged by a doctor.
- Women who can have children must have a negative pregnancy test before starting treatment.
Exclusion Criteria
- Previous radiation to the affected breast area that would interfere with new treatment.
- Lymph nodes involved that require extensive radiation beyond the breast.
- Any serious uncontrolled illness.
- Stage IV breast cancer.
- Diagnosis of Paget's disease of the nipple.
- Other cancers that could affect the study's safety or results.
- Pregnant or breastfeeding women.
- Anyone who may not be able to follow the study procedures or schedule.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope at Arcadia | 91007 | Arcadia | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| City of Hope Antelope Valley | 93534 | Lancaster | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
| City of Hope Upland | 91786 | Upland | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.