Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- acute radiation induced dermatitis by CTCAE within 3 months
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.
Detailed Description
OBJECTIVES: Primary: To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery. Secondary: To determine the short term cosmetic and quality of life of the participants treated with this regimen. To determine the local control of the participants treated with this regimen. OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear. PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.
Investigators
Yu Tang
Doctor
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •female, aged between 18-70
- •pathological confirmed breast invasive carcinoma
- •patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy
- •stage p T 1-2 N 0
- •metastasis omitted by routine examinations in 1 months before enrollment
- •complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count \> 1.8 \*10\^9/L, hemoglobin \> 8.0g/dl, platelet \> 75 \* 10\^9/L
- •hepatic and renal function in 2 weeks prior to study entry should be normal
- •study entry within 60 days from whichever comes later: surgery or last chemotherapy
- •women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry
- •signs study specific informed consent prior to study entry
Exclusion Criteria
- •breast cancer with stage III/III (AJCC 7th)
- •occult breast cancer
- •in-situ breast carcinoma
- •bilateral breast cancer
- •male breast cancer
- •breast lymphoma or breast sarcoma
- •combined with Paget's disease
- •received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy
- •positive surgical margin
- •axillary lymph nodes dissection or sentinel lymph node biopsy omitted
Outcomes
Primary Outcomes
acute radiation induced dermatitis by CTCAE within 3 months
Time Frame: 3 months
radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation.
Secondary Outcomes
- breast cosmetic result as measured by Harvard scale of breast cosmesis (excellent, good, fair, poor) every 3 months for 1year(every 3 months for 1year)
- quality of life as measured by Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) every 3 months for 1 year(every 3 months for 1 year)
- in-breast recurrence rate at 1 year of radiation completion(1 year)
- late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation(3 months to 1 year)
- quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year(every 3 months for 1 year)