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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiotherapy | Experimental | 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. |
|
| Conventional Irradiation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiotherapy | Radiation | daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastasis free survival (DMFS) | Distant metastasis is defined as clinical detection of metastatic disease beyond the chest wall and/or regional lymph nodes or death or last visit. Distant metastasis free survival (DMFS) is defined as the interval starting from the date of randomization until to the event. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Yu, MD, PhD | Contact | +86-13817893133 | stephanieyxl@hotmail.com | |
| Jurui Luo, PhD | Contact | +86-13162996951 | juruiluo@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoli Yu, MD, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guizhou Provincial People's Hospital | Not yet recruiting | Guiyang | Guizhou | 550002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38802888 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
| Conventional fractionated Radiotherapy | Radiation | daily fractions, 2 Gy per fraction, five fractions per week |
|
|
| Disease free survival (DFS) | Defined as the interval from the date of randomization to any disease recurrence or death or last visit. | 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) | Defined as the interval from the date of randomization to death or last visit. | 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 | Acute toxicity (development of radiation dermatitis, pruritus, pain, radiation esophagitis, and radiation pneumonitis) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group), 2 weeks and 3 months after the last fraction received. | 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 | Late toxicity (change of skin in irradiated area，impaired shoulder movement ，impaired shoulder movement, brachial plexopathy,ischemic heart disease) will be assessed according to toxicity criteria of CTCAE version 4.03 | 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 | Development of dyspigmentation, telangiectasia in irradiated area and radiation pulmonary fibrosis will be assessed according to toxicity criteria of LENT-SOMA | before treatment, every year after the last fraction received through 10 years |
| Harvard/NSABP/RTOG Breast Cosmesis Grades of patients | The cosmetic outcomes will be evaluated by radiation oncologists, nurses and patients using digital photographs and Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. Harvard/NSABP/RTOG Breast Cosmesis Grading Scale classifies the overall aesthetic results in four categories from excellent, good, fair to poor. | before treatment, every year after the last fraction received through 10 years |
| Quality of Life Score assessed by EORTC-QLQ-C30 (version 3) | Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3) | 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) | Patients' quality of life will be assessed using self-administered questionnaire EORTC breast-cancer module (BR23) | 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 | peripheral blood lymphocytes will be assessed before, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group). The number and percentage of peripheral blood lymphocytes will be assessed the correlation with the grade of acute toxicity assessed by CTCAE 4.03 | before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation |
| Suzhou Municipal hospital | Recruiting | Suzhou | Jiangsu | 215000 | China |
|
| The Second Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | 116044 | China |
|
| Shanghai Huangpu District Central Hospital | Recruiting | Shanghai | Shanghai Municipality | 200002 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |