Status:
COMPLETED
Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
Lead Sponsor:
University of Utah
Conditions:
Ductal Breast Carcinoma In Situ
Invasive Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Adjuvant radiation therapy (RT) plays an important role in successful breast conservation in early-stage breast cancer and has been shown to significantly reduce the risk of breast cancer recurrence o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Prior radiation therapy to the chest, neck or axilla
- Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
- History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
- Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
- Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable
- Co-existing medical conditions with life expectancy \< 5 years
- Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
- Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
- Neuroendocrine carcinoma or sarcoma histology
- Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03345420
Start Date
December 12 2017
End Date
June 26 2025
Last Update
December 30 2025
Active Locations (1)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112