Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery

Study 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.

Official Title
-----------------
Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Radiation: Radiation therapy


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIB group<br>Radiation therapy: daily 5 days per week for 3 weeks. 43.5 Gy in 15 fractions to the whole breast 49.5 Gy in 15 fractions to the tumor bed boost | Radiation: Radiation therapy<br>* Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks. Intensity modulated radiation treatment is used.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute radiation induced dermatitis by CTCAE within 3 months | radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation | any radiation induced toxicity occurring after the radiation | 3 months to 1 year | 
| breast cosmetic result as measured by Harvard scale of breast cosmesis (excellent, good, fair, poor) every 3 months for 1year | breast cosmetic evaluation after breast conserving surgery and radiation, using Harvard scale. | 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 | Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) is used to evaluated the quality of life: all scale range: 0-144; sub-scale range: physical well being: 0-28; social well being: 0-28; emotional well being 0-24; functional well being 0-28; additional consideration: 0-36; the higher the better | every 3 months for 1 year | 
| quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year | Functional Assessment of Breast Cancer Treatment Outcome Scale(BCTOS) is used to evaluated the quality of life. the range of BCTOS is 22-88, the smaller the better | every 3 months for 1 year | 
| in-breast recurrence rate at 1 year of radiation completion | recurrence occurred in the treated breast. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypofractionated radiation, breast cancer, breast conserving surgery, simultaneous boost radiation