Super Hypofractionated Irradiation For Whole Breast Treatment

Breast Cancer Clinical Trial

— SHIFT  

Official title:

Super Hypofractionated Irradiation For Whole Breast Treatment: A Prospective, Single-arm Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04926766
• Other study ID #: SHF-WBI
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2021
• Est. completion date: December 10, 2026

Study information

• Verified date: August 2023
• Source: Ruijin Hospital
• Contact: Lu Cao, PhD
• Phone: +86-021-64370045
• Email: cl11879[@]rjh.com.cn; caolu_163[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, distant metastasis, death, contralateral breast cancer and quality of life.

Description:

Eligible breast cancer patients will receive SHF-WBI of 5.2 Gy in 5 fractions to ipsilateral whole breast within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of the radiation oncologist. All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. Patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, distant metastasis, death and quality of life. Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after SHF-WBI comparing to hypofractionated whole breast irradiation(40-42.5Gy/15-16Fx) and lost rate of follow up of 10%. In total 217 patients are needed to be recruited.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 217
• Est. completion date: December 10, 2026
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent
• Aged =18 years old
• breast conservation surgery
• unilateral histologically confirmed invasive breast carcinoma or Ductal Carcinoma In Situ (DCIS)
• For patients with invasive breast cancer,negative axillary lymph nodes or micrometastasis only
• Karnofsky Performance Status =80, and Life expectancy of >5 years
• Histologically negative surgical margin for invasive breast carcinoma or a minimum negative margin width of = 3mm for DCIS
• Surgery wound healed without infection
• ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
• Female patients of child-producing potential must agree to use effective contraception for up to 1 month before study treatment and the duration of study participation

Exclusion Criteria:

• Histological involvement of supraclavicular lymph node
• Histologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
• Pregnant or lactating women
• Severe non-neoplastic medical comorbidities
• Diagnosis of non-breast malignancy within 5 years preceding enrollment (excluding lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix, adenocarcinoma in situ,which are permitted).
• simultaneous contralateral breast cancer
• Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
• Active collagen vascular disease
• Definitive histological or radiologic evidence of distant metastatic disease
• Evidence of T4 disease

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• External Beam radiotherapy using IMRT technique
2600cGy/ 5 fractions / 1 weeks to ipsilateral whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life-EORTC QLQ-C30	Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30	6 months
Other	Quality of Life-EORTC QLQ-C30	Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30	5 years
Other	Quality of Life-EORTC QLQ-BR23	Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23	6 months
Other	Quality of Life-EORTC QLQ-BR23	Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23	5 years
Primary	Cumulative complication rate of =Grade 2 Acute Radiation-induced Toxicity	Within time from the beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation induced toxicities will be assessed and recorded using Common Terminology Criteria for Adverse Events (CTCAE) 5.0.	6 months
Secondary	Cumulative complication rate of =Grade 2 Late Radiation-induced Toxicity	Within time from 6 months after completion of radiotherapy to 5 years after completion of radiotherapy, any late toxicity will be assessed and recorded using the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 5.0	5 years
Secondary	Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale	The cosmetic outcomes will be evaluated at 6 months after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast	6 months
Secondary	Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale	The cosmetic outcomes will be evaluated at 5 years after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast	5 years
Secondary	Locoregional recurrence	any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area(including supraclavicular, infraclavicular or internal mammary lymph nodes)	5 years
Secondary	Distant metastasis free survival (DMFS)	The time from the date of enrollment to any recurrence of tumor at distant sites or death from any cause	5 years
Secondary	Invasive recurrence-free survival (IRFS)	The time from the date of enrollment to any invasive recurrence of tumor or death from any cause	5 years
Secondary	Overall survival	The time from the date of enrollment to the date of death from any cause	5 years