Study on Ultra Hypo-fractionated Radiation Therapy with Boost for Early-Stage Breast Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials ID:NCT06902311
This clinical trial is testing a new radiation therapy approach for early-stage breast cancer, aiming to reduce treatment visits while maintaining effectiveness. The study focuses on a 5-session radiation treatment with an added boost to the tumor area.
Patient Parameters
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Program Overview
The study is exploring a new method of radiation therapy for early-stage breast cancer and ductal carcinoma in situ. It involves a 5-session treatment plan that includes a simultaneous boost to the tumor area, aiming to reduce the number of treatment visits while still effectively lowering the risk of cancer returning. This approach builds on previous research showing that a shorter, 1-week course of radiation can be as effective as the traditional 3-week course.
Description
This study involves women aged 50 and older who have early-stage breast cancer and are recommended to receive whole breast radiation therapy. The treatment consists of 5 radiation sessions given every other day, excluding weekends. The whole breast receives a total dose of 26 Gy, while the area where the tumor was removed gets an additional boost to 30 Gy.
The main goal is to see if this treatment causes moderate to severe side effects in the breast and chest area. Doctors and patients will evaluate these effects 12 months after treatment. The study will also look at quality of life and cancer control 24 months after treatment.
Researchers believe that this 5-session treatment with a boost will have acceptable side effects and provide good quality of life and effective cancer control, similar to traditional methods.
Eligibility Criteria
Inclusion Criteria
- Women aged 50 or older with confirmed early-stage breast cancer or ductal carcinoma in situ.
- Have completed breast-conserving surgery, with or without lymph node biopsy or dissection.
- Planned to receive standard whole breast radiation therapy with a boost to the tumor area.
- Can participate in another clinical trial if it doesn't interfere with this study.
- Willing to provide written consent and allow access to personal health information.
Exclusion Criteria
- Undergoing breast reduction surgery that affects the tumor area.
- Having cancer in both breasts that requires radiation.
- Evidence of cancer spread to other parts of the body.
- Previous radiation to the same breast or chest area.
- Having autoimmune conditions or collagen vascular diseases.
- Having large tumors (pT4).
- Recommended to receive additional radiation to lymph nodes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of North Carolina | 27599 | Chapel Hill | North Carolina |
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