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The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.
In this study, patients with ipsilateral supraclavicular lymph node positive breast cancer were selected as research subjects. Randomized controlled method was used to study the effects of surgical dissection of supraclavicular lymph node combined with radiotherapy and radiotherapy alone on progression-free survival and overall survival of breast cancer. This RCT aims to explore the best treatment method for ipsilateral supraclavicular lymph node metastasis and to provide the basis for guiding the precise treatment of supraclavicular lymph node chain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supraclavicular lymph node dissection combined with radiotherapy | Experimental | Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive standard radiotherapy after supraclavicular lymph node dissection. |
|
| radiotherapy | Placebo Comparator | Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive only standard radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraclavicular lymph node dissection combined with radiotherapy | Procedure | Breast cancer patients in the expreimental cohort with only ipsilateral supraclavicular lymph node metastasis were first treated with supraclavicular lymph node dissection and received standard radiotherapy after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease-free survival | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival | 3-year |
| OS | Overall survival | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | Pathological complete response rate | 1-year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Wei, Professor | Contact | +8613822278328 | weiwd@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weidong Wei, Professor | Sun Yat-sen University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10561205 | Background | Recht A, Gray R, Davidson NE, Fowble BL, Solin LJ, Cummings FJ, Falkson G, Falkson HC, Taylor SG 4th, Tormey DC. Locoregional failure 10 years after mastectomy and adjuvant chemotherapy with or without tamoxifen without irradiation: experience of the Eastern Cooperative Oncology Group. J Clin Oncol. 1999 Jun;17(6):1689-700. doi: 10.1200/JCO.1999.17.6.1689. | |
| 11849781 |
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Supraclavicular lymph node dissection combined with radiotherapy versus radiotherapy alone
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|
| radiotherapy | Radiation | Patients in the control group received only standard radiation therapy. |
|
| Chen SC, Chen MF, Hwang TL, Chao TC, Lo YF, Hsueh S, Chang JT, Leung WM. Prediction of supraclavicular lymph node metastasis in breast carcinoma. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):614-9. doi: 10.1016/s0360-3016(01)02680-3. |
| 24516053 | Background | Chang XZ, Yin J, Sun J, Zhang XH, Cao XC. A retrospective study of different local treatments in breast cancer patients with synchronous ipsilateral supraclavicular lymph node metastasis. J Cancer Res Ther. 2013 Nov;9 Suppl:S158-61. doi: 10.4103/0973-1482.122514. |
| 26155293 | Background | Jung J, Kim SS, Ahn SD, Lee SW, Ahn SH, Son BH, Lee JW, Choi EK. Treatment Outcome of Breast Cancer with Pathologically Proven Synchronous Ipsilateral Supraclavicular Lymph Node Metastases. J Breast Cancer. 2015 Jun;18(2):167-72. doi: 10.4048/jbc.2015.18.2.167. Epub 2015 Jun 26. |
| 12111882 | Background | Lakatos E. Designing complex group sequential survival trials. Stat Med. 2002 Jul 30;21(14):1969-89. doi: 10.1002/sim.1193. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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