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| Name | Class |
|---|---|
| The Second People's Hospital of Huai'an | OTHER |
| lian shui county People's Hospital | UNKNOWN |
| xuyi People's Hospital | UNKNOWN |
| Chinese People's Liberation Army No. 82 Hospital |
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The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| concurrent chemoradiotherapy group | Experimental | All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin). |
|
| radiotherapy group | Active Comparator | All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel plus cisplatin | Drug | cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。 | From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From the date of randomization until the date of death | From date of randomization to death from any cause, assessed up to 3 years |
| treatment-related toxicities | Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Peiple's Liberation Army No.82 Hospital | Huai'an | Jiangsu | 223300 | China | ||
| Huai'an second peiple's Hospital |
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| UNKNOWN |
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| radiotherapy | Radiation | radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week) |
|
| From the date of randomization until six months after treatment completion |
| Quality of life(QOL) | Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months. | 1 year |
| Huai'an |
| Jiangsu |
| 223300 |
| China |
| Lianshui County Peoples Hospital | Huai'an | Jiangsu | 223300 | China |
| xuyi peiple's Hospital | Xucheng | Jiangsu | 211700 | China |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
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