Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery
Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery
1 other identifier
interventional
720
1 country
4
Brief Summary
Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jun 2010
Typical duration for phase_3 breast-cancer
4 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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJanuary 12, 2026
October 1, 2018
5.3 years
August 9, 2011
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
in-breast recurrence rate
evidence of ipsilateral breast local recurrence confirmed by histology
5 year
Secondary Outcomes (5)
regional node recurrence rate
5 year
disease-free survival
5 year
overall survival
5 year
acute toxicity
6 months
late complication
3 -10 year
Study Arms (2)
hypofractionation radiotherapy
EXPERIMENTALirradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.
conventional fractionation radiotherapy
ACTIVE COMPARATORirradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
Interventions
one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
Eligibility Criteria
You may qualify if:
- KPS\>=60
- histology confirmed invasive breast cancer
- received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
- surgical margins negative
- primary tumor ≤5cm in the largest diameter
- no internal mammary node or supraclavicular node metastases or distant metastasis
- can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
- for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
- for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
- patients signed written inform consent form
You may not qualify if:
- ductal carcinoma in situ
- prior neoadjuvant chemotherapy
- prior breast cancer history
- bilateral breast cancer
- pregnant or during lactation
- prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
- active collagen vascular disease
- prior neoadjuvant hormone therapy
- immediate ipsilateral breast reconstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Beijing hospital
Beijing, Beijing Municipality, 100730, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Related Publications (1)
Wang SL, Fang H, Hu C, Song YW, Wang WH, Jin J, Liu YP, Ren H, Liu J, Li GF, Du XH, Tang Y, Jing H, Ma YC, Huang Z, Chen B, Tang Y, Li N, Lu NN, Qi SN, Yang Y, Sun GY, Liu XF, Li YX. Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China. J Clin Oncol. 2020 Nov 1;38(31):3604-3614. doi: 10.1200/JCO.20.01024. Epub 2020 Aug 11.
PMID: 32780661DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ye-xiong Li, M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Shu-lian Wang, M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 10, 2011
Study Start
June 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2018
Last Updated
January 12, 2026
Record last verified: 2018-10