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

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Radiation: Radiation therapy

• Registration Number: NCT03320421
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Status Verified: 2019-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIB group	Radiation therapy	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

Primary Outcome Measures

Name	Time	Method
acute radiation induced dermatitis by CTCAE within 3 months	3 months	radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation.

Secondary Outcome Measures

Name	Time	Method
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	breast cosmetic evaluation after breast conserving surgery and radiation, using Harvard scale.
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	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
in-breast recurrence rate at 1 year of radiation completion	1 year	recurrence occurred in the treated breast.
late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation	3 months to 1 year	any radiation induced toxicity occurring after the radiation
quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year	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

Trial Locations

Locations (1)

National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China