Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial
1 other identifier
interventional
4,052
1 country
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jul 2018
Longer than P75 for not_applicable breast-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 6, 2019
CompletedFirst Posted
Study publicly available on registry
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
ExpectedJuly 18, 2019
July 1, 2019
5 years
July 6, 2019
July 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Loco-regional recurrence (LRR)
Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes).
5 years
Secondary Outcomes (10)
Distant metastasis free survival (DMFS)
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)
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)
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
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
before treatment, every year after the last fraction received through 10 years
- +5 more secondary outcomes
Study Arms (2)
Hypofractionated Radiotherapy
EXPERIMENTAL40 Gy/15 fractions irradiation is delivered to the whole breast, 2.67 Gy per fraction, 5 fractions weekly. Tumor bed is boosted to 48 Gy simultaneously, 3.2 Gy per fraction, 5 fractions weekly.
Conventional Irradiation
ACTIVE COMPARATOR50 Gy/25 fractions irradiation is delivered to the whole breast, 2 Gy per fraction, 5 fractions weekly. Additional 10 Gy/5 fractions is boosted to tumor bed sequentially, 2 Gy per fraction, 5 fractions weekly.
Interventions
daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
daily fractions, 2 Gy per fraction, five fractions per week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (5)
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Suzhou Municipal hospital
Suzhou, Jiangsu, 215000, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116044, China
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, 200002, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
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: 38802888DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoli Yu, MD, PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of department of radiation oncology
Study Record Dates
First Submitted
July 6, 2019
First Posted
July 18, 2019
Study Start
July 1, 2018
Primary Completion
June 30, 2023
Study Completion (Estimated)
June 30, 2028
Last Updated
July 18, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share