Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery

Last updated: July 17, 2019
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT04025164
FDRT-BC007
  • Ages 18-70
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Age18-70 years

  • Imaging examination confirmed single lesion. if the tumor is multiple, it needs to beremoved by single quadrantectomy

  • Receive breast conserving surgery with negative margins

  • Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillarylymph node dissection. If the sentinel lymph node is negative, the axillary lymph nodedissection can be omitted. If it is positive, level I/II axillary lymph nodedissection with or more than 10 lymph nodes is needed.

  • The tumor bed is labeled with clips and it can be drawn on the treatment planningsystem.

  • 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

  • KPS≥80

  • Signed informed consent

Exclusion

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 (inthe 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 theskin

  • 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 orfollow up

  • Unable or unwilling to sign informed consent

Study Design

Total Participants: 4052
Study Start date:
July 01, 2018
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou 550002
    China

    Site Not Available

  • Suzhou Municipal hospital

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116044
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanghai Huangpu District Central Hospital

    Shanghai, Shanghai 200002
    China

    Active - Recruiting

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