Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
NCT ID: NCT04025164
Last Updated: 2019-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4052 participants
INTERVENTIONAL
2018-07-01
2028-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionated Radiotherapy
40 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.
Hypofractionated Radiotherapy
daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
Conventional Irradiation
50 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.
Conventional fractionated Radiotherapy
daily fractions, 2 Gy per fraction, five fractions per week
Interventions
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Hypofractionated Radiotherapy
daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
Conventional fractionated Radiotherapy
daily fractions, 2 Gy per fraction, five fractions per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiaoli Yu
Associate Professor of department of radiation oncology
Principal Investigators
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Xiaoli Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Suzhou Municipal hospital
Suzhou, Jiangsu, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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FDRT-BC007
Identifier Type: -
Identifier Source: org_study_id
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