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

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

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.

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.

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