Super Hypofractionated Irradiation for Whole Breast Treatment

NCT04926766 | Active Not Recruiting

• 1 other identifier: SHF-WBI
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cumulative complication rate of ≥Grade 2 Late Radiation-induced Toxicity

  5 years

• Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale

  6 months

• Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale

  5 years

• Locoregional recurrence

  5 years

• Distant metastasis free survival (DMFS)

  5 years

Other Outcomes (4)

• Quality of Life-EORTC QLQ-C30

  6 months

• Quality of Life-EORTC QLQ-C30

  5 years

• Quality of Life-EORTC QLQ-BR23

  6 months

Study Arms (1)

SHF-WBI

EXPERIMENTAL

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

Radiation: External Beam radiotherapy using IMRT technique

Interventions

External Beam radiotherapy using IMRT technique 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

SHF-WBI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jiayi Chen, PhD, MD

  Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine

  STUDY CHAIR

• Lu Cao, PhD, MD

  Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Radiation Oncology

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 15, 2021
• Study Start: January 23, 2021
• Primary Completion: January 10, 2024
• Study Completion (Estimated): July 10, 2028
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)