Clinical trial NCT03320421: Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery
Official title: Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: hypofractionated radiation
breast cancer
breast conserving surgery
simultaneous boost radiation
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2017-10-25
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: acute radiation induced dermatitis by CTCAE within 3 months
timeFrame: 3 months
Secondary outcomes:
measure: late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation
timeFrame: 3 months to 1 year
measure: breast cosmetic result as measured by Harvard scale of breast cosmesis (excellent, good, fair, poor) every 3 months for 1year
timeFrame: every 3 months for 1year
measure: quality of life as measured by Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) every 3 months for 1 year
timeFrame: every 3 months for 1 year
measure: quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year
timeFrame: every 3 months for 1 year
measure: in-breast recurrence rate at 1 year of radiation completion
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Cancer Hospital/Institution, Chinese Academic Medical Sciences and Peking Union Medical College
name: Yexiong Li, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.
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citation: START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19.
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citation: Hamilton DG, Bale R, Jones C, Fitzgerald E, Khor R, Knight K, Wasiak J. Impact of tumour bed boost integration on acute and late toxicity in patients with breast cancer: A systematic review. Breast. 2016 Jun;27:126-35. doi: 10.1016/j.breast.2016.03.002. Epub 2016 Apr 22.
citation: Chadha M, Vongtama D, Friedmann P, Parris C, Boolbol SK, Woode R, Harrison LB. Comparative acute toxicity from whole breast irradiation using 3-week accelerated schedule with concomitant boost and the 6.5-week conventional schedule with sequential boost for early-stage breast cancer. Clin Breast Cancer. 2012 Feb;12(1):57-62. doi: 10.1016/j.clbc.2011.09.002. Epub 2011 Nov 6.
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