Super Hypofractionated Irradiation for Whole Breast Treatment

NCT ID: NCT04926766

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-23
• Study Completion Date: 2028-07-10

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Keywords

Whole breast irradiation; IMRT; Super Hypofractionated radiotherapy; Super Hypofractionated irradiation to tumor bed boost

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHF-WBI

Patients with an indication for whole breast irradiation will receive 5.2 Gy in 5 fractions to whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist

Group Type: EXPERIMENTAL

External Beam radiotherapy using IMRT technique

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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, Pulmonary 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

JIAYI CHEN

Chief of Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayi Chen, PhD, MD

Role: STUDY_CHAIR

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine

Lu Cao, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHF-WBI

Identifier Type: -

Identifier Source: org_study_id