Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer (NCT03345420) | Clinical Trial Compass
CompletedPhase 2
Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
United States102 participantsStarted 2017-12-12
Plain-language summary
This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast
* Final pathologic Tis, T1-T3, all must be N0 and M0 status.
* Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia
* Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields
* Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation.
* Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =\< 7 days prior to registration
* A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
* Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
* Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exc…
What they're measuring
1
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Timeframe: Up to 24 months post radiation therapy (RT)