Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
City of Hope Medical Center
Summary
This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.
Description
PRIMARY OBJECTIVE: I. To evaluate the impact of UF-WBI + CB as assessed by patient-reported Global Cosmesis Score (GCS) at 1 year. SECONDARY OBJECTIVES: I. To characterize the patient-reported cosmetic appearance of the breast over time, as assessed by GCS. II. To determine short- and long-term physician-reported cosmetic appearance of the breast, as assessed by GCS. III. To evaluate the acute and late patient-reported radiation-associated toxicities. IV. To evaluate the acute and late physician-reported radiation-associated toxicities. V. To estimate: Va. 5-year in-breast recurrence;…
Eligibility
- Age range
- 40+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age: ≥ 40 years * Female * Ability to read and understand English for questionnaires * Histologically confirmed breast cancer * Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed * Patients must have undergone breast conserving surgery. Re-excision for negative margins is allowed * Patients must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection) * Must have at least o…
Interventions
- ProcedureCone-Beam Computed Tomography
Undergo CBCT
- RadiationHypofractionated External Beam Radiation Therapy
Undergo UF-WBI with CB
- OtherQuestionnaire Administration
Ancillary studies
- RadiationRadiation Boost
Undergo UF-WBI with CB
- RadiationWhole Breast Irradiation
Undergo UF-WBI with CB
Locations (7)
- City of Hope at ArcadiaArcadia, California
- City of Hope Medical CenterDuarte, California
- City of Hope at Irvine LennarIrvine, California
- City of Hope Antelope ValleyLancaster, California
- City of Hope South PasadenaSouth Pasadena, California
- City of Hope at South BayTorrance, California