Status:
COMPLETED
Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
- regional lymph nodes radiation needed
- boost volume larger than 1/4 of the whole breast
- tumor bed unable to recognize on CT
- prior invasive malignant tumor history
- prior radiation to thoracic
- connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc.
- severe, active co-morbidity, defined as follows:
- unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- severe, acute bacterial or fungal infection within the last 2 weeks
- chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days
- pregnant women
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03320421
Start Date
January 1 2017
End Date
January 1 2019
Last Update
January 31 2019
Active Locations (1)
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1
National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021