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NCT Number: NCT04926766

Super Hypofractionated Irradiation for Whole Breast Treatment

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity

    Time frame: 6 months

    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.

Secondary outcomes

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

    Time frame: 5 years

    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

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

    Time frame: 6 months

    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

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

    Time frame: 5 years

    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

  4. Locoregional recurrence

    Time frame: 5 years

    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. Distant metastasis free survival (DMFS)

    Time frame: 5 years

    The time from the date of enrollment to any recurrence of tumor at distant sites or death from any cause

  6. Invasive recurrence-free survival (IRFS)

    Time frame: 5 years

    The time from the date of enrollment to any invasive recurrence of tumor or death from any cause

  7. Overall survival

    Time frame: 5 years

    The time from the date of enrollment to the date of death from any cause

Other outcomes

  1. Quality of Life-EORTC QLQ-C30

    Time frame: 6 months

    Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30

  2. Quality of Life-EORTC QLQ-C30

    Time frame: 5 years

    Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30

  3. Quality of Life-EORTC QLQ-BR23

    Time frame: 6 months

    Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23

  4. Quality of Life-EORTC QLQ-BR23

    Time frame: 5 years

    Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Super Hypofractionated Irradiation for Whole Breast Treatment: a Prospective, Single-arm Trial

Acronym: SHIFT

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Jun 15, 2021
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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