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| Name | Class |
|---|---|
| Hebei Medical University Fourth Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Beijing Hospital |
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The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy or breast-conserving surgery.
Eligible patients are randomized into 2 groups: chest wall/whole breast and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall/whole breast and supraclavicular nodal +-axillary nodal irradiation. The prescription dose is 50 Gy in 25 fractions over 5 weeks or 43.5Gy in 15 fractions over 3 weeks. Breast cancer patients treated with breast-conserving surgery will receive tumor bed boost.
During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| internal mammary nodal irradiation | Experimental | chest wall/whole breast and supraclavicular nodal+-axillary plus internal mammary nodal irradiation |
|
| no-internal mammary nodal irradiation | Active Comparator | ipsilateral chest wall/whole breast and supraclavicular +-axillary nodal irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| internal mammary nodal irradiation | Radiation | chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Patients treated with breast-conserving surgery will receive tumor bed boost. Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional. |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | failure: relapse of ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal or distant metastasis or contralateral invasive breast cancer or death due to any cause. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the incidence of death due to any cause. | 5 years |
| cumulative internal mammary nodal recurrence | ipsilateral internal mammary nodal relapse during follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Translational Research | Circulating blood markers in relation to efficacy and toxicity | 5 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu-lian Wang, M.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Ye-xiong Li, M.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34742270 | Derived | Zhao XR, Fang H, Tang Y, Hu ZH, Jing H, Liang L, Yan XN, Song YW, Jin J, Liu YP, Chen B, Tang Y, Qi SN, Li N, Lu NN, Men K, Hu C, Zhang YH, Li YX, Wang SL. POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial. BMC Cancer. 2021 Nov 6;21(1):1185. doi: 10.1186/s12885-021-08852-y. |
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Owing to concerns regarding patient privacy.
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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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| OTHER_GOV |
| Liaoning Cancer Hospital & Institute | OTHER |
| Jilin Provincial Tumor Hospital | OTHER |
| Tangshan People's Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| West China Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Zhongnan Hospital | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Fudan University | OTHER |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
| Air Force Military Medical University, China | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Lanzhou University First Hospital | UNKNOWN |
| Jiangsu Province Hospital of Traditional Chinese Medicine | OTHER |
| Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center | OTHER |
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|
| no internal mammary nodal irradiation | Radiation | chest wall/whole breast and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional. |
|
| 5 years |
| cumulative locoregional recurrence | ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal relapse during follow up. | 5 years |
| distant metastasis | the incidence of first relapse beyond locoregional region. | 5 years |
| contralateral non-invasive breast cancer or other malignant tumors | the incidence of contralateral invasive breast cancer or other malignant tumors developed after enrollment. | 5 years |
| major cardiovascular events | the incidence of death due to coronary heart disease or other heart disease, development of myocardial infarction, coronary recanalization, or hospitalization for a major cardiovascular events (such as heart failure, valvular disease, arrhythmia, unstable angina, or other major cardiovascular event). | 5 years |
| incidence of adverse events | graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 3.0. | 5 years |
| quality of life | questionaire analysis with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 scale | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |