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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
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The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.
Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as conventional radiotherapy in breast cancer patients with an indication for regional nodal irradiation. Eligible breast cancer patients are randomized 1:1 into the following two groups: hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) and conventional radiotherapy of 2Gy for 25 fractions (and sequential tumor bed boost of 2 Gy for 5 fractions in patients with intact breast). The dose was prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). All patients are treated with IMRT. The primary endpoint is locoregional recurrence. Patients will be followed at least 5 years after radiotherapy to evaluated over survival, distant metastasis, toxicity and life quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated radiotherapy | Experimental | Patients with an indication for regional nodal irradiation will received 2.67 Gy for 16 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67 Gy for 4 fractions following breast conserving surgery |
|
| Conventional radiotherapy | Active Comparator | Patients with an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | 4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional recurrence (LRR) | any first recurrence confirmed by histology or cytology in the ipsilateral chest wall or breast or regional nodes areas (including axillary, supraclavicular, infraclavicular lymph nodes or IMN) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastasis free survival (DMFS) | the time from the date of randomization to any recurrence of tumor at distant sites or death from any cause. | 5 years |
| Invasive recurrence-free survival (IRFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life-EORTC QLQ-C30 | The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30 | 1 years |
Inclusion criteria :
Exclusion criteria:
Notes for exlusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia-Yi Chen | Contact | +86-021-64370045 | 602400 | chenjiayi0188@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia-Yi Chen | Ruijin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36581983 | Derived | Xie J, Xu F, Zhao Y, Cai G, Lin X, Zhu Q, Lin Q, Yao Y, Xu C, Cai R, Wang S, Tang X, Chen C, Zheng S, Chen M, Chen M, Qian X, Shen C, Li J, Xu H, Xu F, Han Y, Li M, Ou D, Shen KW, Qi WX, Cao L, Huang X, Chen J. Hypofractionated versus conventional intensity-modulated radiation irradiation (HARVEST-adjuvant): study protocol for a randomised non-inferior multicentre phase III trial. BMJ Open. 2022 Sep 1;12(9):e062034. doi: 10.1136/bmjopen-2022-062034. |
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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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| Shanghai Zhongshan Hospital |
| OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Affiliated Hospital of Jiangnan University | OTHER |
| Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) | UNKNOWN |
| The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China | OTHER |
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| Conventional radiotherapy | Radiation | 5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast |
|
|
the time from the date of randomization to any invasive recurrence of tumor, distant metastases or death from any cause and second invasive primaries, including invasive neoplasms of the breast.
| 5 year |
| over survival (OS) | the time from the date of randomization to the date of death from any cause or end of the follow-up. | 5 years |
| Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale | The time from the date of randomization to 5 years after completion of radiotherapy, the cosmetic outcomes will be evaluated before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/(National Surgical Adjuvant Breast and Bowel Project) NSABP/ (Radiation Therapy Oncology Group) RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast. | 5 years |
| Number of Participants with ≥Grade1 Acute Radiation-induced Toxicity | within time from beginning of RT to 6 months after completion of RT assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | 6 months |
| Number of Participants with ≥Grade1 Late Radiation-induced Toxicity | within time from 6 months after completion of RT to 5 years after completion of RT assessed according to the RTOG/ European Organization for Research on Treatment of Cancer (EORTC） Late Radiation Morbidity Scoring Schema and CTCAE version 3.0 | 5 years |
| Reconstruction complications | number of participants with any reconstruction complications (flap necrosis, capsular contracture, infection, loss of implant/expander or flaps, et al) and the interval between the RT and reconstruction complications will be recorded. Patient reported outcome with reconstruction will be evaluated by Breast-Q questionnaires before RT and 12 months after RT. | 5 years |
| Quality of Life-EORTC QLQ-C30 | The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30 | 5 years |
| Quality of Life-EORTC QLQ-BR23 | The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23 | 1 years |
| Quality of Life-EORTC QLQ-BR23 | The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23 | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |