Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery

  • STATUS
    Recruiting
  • End date
    Jun 30, 2028
  • participants needed
    4052
  • sponsor
    Fudan University
Updated on 23 January 2021
metastasis
HER2
erbb2
invasive breast cancer
axillary lymph node dissection
sentinel node
breast-conserving surgery
sentinel lymph node biopsy
ki-67

Summary

The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery

Description

Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group.

Patients in HF-RT group will receive 40 Gy/15 fractions irradiation to the whole breast with/without regional lymphnodes within 3 weeks and the tumor bed is boosted to 48 Gy/15 fractions simutaneously.

Patients in CF-RT group will receive 50 Gy/ 25 fractions irradiation to whole breast with/without regional lymphnodes within 5 weeks and the tumor bed is boosted to 60 Gy/30 fractions sequentially.

The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.

It is hypothesized that hypofractionated radiotherapy is non inferior to conventional fractionated radiotherapy in terms of tumor loco-regional control for patients after breast conserving surgery.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Hypofractionated Radiotherapy, Conventional fractionated radiotherapy
Clinical Study IdentifierNCT04025164
SponsorFudan University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer Diagnosis or cancer, breast or Breast Cancer or breast carcinoma?
Female
Age18-70 years
Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy
Receive breast conserving surgery with negative margins
Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed
The tumor bed is labeled with clips and it can be drawn on the treatment planning system
Pathologically confirmed invasive breast cancer
Pathologically stage is T1-3N0-3M0
Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery
No distant metastases
No supraclavicular or internal mammary nodes metastases
No neoadjuvant chemotherapy
Fit for postoperative radiotherapy. No contraindications to radiotherapy
KPS80
Signed informed consent

Exclusion Criteria

T4 or M1 breast cancer
Supraclavicular or internal mammary nodes metastases
Pathologically confirmed DCIS only without an invasive component
Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Multiple lesions can not be removed by single quadrantectomy
Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast)
KPS 70
Patients with severe non-malignant comorbidity in cardiovascular or respiration system
Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
Previous radiotherapy to the chest wall or regional lymph node areas
Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
Pregnant or lactating
Conditions indicating that the patient cannot go through the radiation therapy or follow up
Unable or unwilling to sign informed consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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