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Recruiting NCT04025164

Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypofractionated Radiotherapy, Conventional fractionated Radiotherapy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial

Overview

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

Detailed 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.

Interventions

  • Radiation Hypofractionated Radiotherapy
    daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
  • Radiation Conventional fractionated Radiotherapy
    daily fractions, 2 Gy per fraction, five fractions per week

Primary outcome measures

  • Loco-regional recurrence (LRR) [Time frame: 5 years]
Secondary outcome measures (10)
  • Distant metastasis free survival (DMFS) [Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years]
  • Disease free survival (DFS) [Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years]
  • Overall survival (OS) [Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years]
  • Number of patients with radiation-induced acute toxicity assesses by CTCAE4.03 [Time frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished]
  • Number of patients with radiation-induced late toxicity assesses by CTCAE4.03 [Time frame: before treatment, every year after the last fraction received through 10 years]
  • Number of patients with radiation-induced late toxicity assesses by LENT-SOMA Toxicity Assessment [Time frame: before treatment, every year after the last fraction received through 10 years]
  • Harvard/NSABP/RTOG Breast Cosmesis Grades of patients [Time frame: before treatment, every year after the last fraction received through 10 years]
  • Quality of Life Score assessed by EORTC-QLQ-C30 (version 3) [Time frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years]
  • Quality of Life Score assessed by EORTC breast-cancer module (BR23) [Time frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years]
  • Number and percentage of peripheral blood lymphocytes [Time frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation]

Eligibility criteria

Inclusion criteria

  • 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
  • KPS≥80
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • Guizhou Provincial People's Hospital — Guiyang
  • Suzhou Municipal hospital — Suzhou
  • The Second Hospital of Dalian Medical University — Dalian
  • Shanghai Huangpu District Central Hospital — Shanghai
  • Fudan University Shanghai Cancer Center — Shanghai

Publications

  • Jin K, Luo J, Yu X, Guo X. Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial. Radiat Oncol. 2024 May 27;19(1):62. doi: 10.1186/s13014-024-02449-y. PMID 38802888

Identifiers

NCT: NCT04025164 · FDRT-BC007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗