Shandong Cancer Hospital Affiliated to Shandong University

  • STATUS
    Recruiting
  • End date
    Nov 21, 2024
  • participants needed
    100
  • sponsor
    Shandong Cancer Hospital and Institute
Updated on 25 February 2022
cancer
carcinoma
breast cancer
invasive breast cancer
breast conserving surgery
whole breast irradiation

Summary

In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.

Details
Condition Early-stage Breast Cancer, Breast Conserving Surgery
Treatment Whole Breast irradiation Plus simultaneous tumor bed Boost
Clinical Study IdentifierNCT02958033
SponsorShandong Cancer Hospital and Institute
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients has had breast conserving surgery
age 18 and 65 years
with a histological diagnosis of invasive carcinoma of the breast
with pathological stage of T1-2N0-1M0
multidisciplinary decision of adjuvant WBI with a boost to the tumor bed
informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria

patients treated with Mastectomy
Need for lymph node irradiation
positive or close( 1 mm) surgical margin
treated with neoadjuvant chemotherapy before surgery
Bilateral malignancy of the breast (synchronous or metachronous)
Pregnant or breastfeeding
Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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