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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Breast Cancer Female

Treatments

Radiation: Radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03320421

NCC2016YQ-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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