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Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy.
Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.
Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy;
control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 ~ 42 days, plus cisplatin first 1~ 4 days and 29 ~ 33 days. Using IMRT radiotherapy.
Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, or S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.
Primary Outcome Measure is complete remission rate.
Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single drug | Experimental | S-1 concurrent Radiotherapy |
|
| Double drug | Active Comparator | S-1 plus cisplatin concurrent Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 concurrent radiotherapy | Other | Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~33 planning target volume times, 60~66 Gray/28~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1~ 14 days, 21 days for a cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate (CR) | Complete response rate of primary tumor which will be measured by endoscopy and computer tomography | Three months after radiotherapy finished |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from treatment completion to patient death | Two years after adjuvant chemotherapy finished |
| Progression-Free-Survival (PFS) | The time from treatment completion to disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Du X, Doctor | Contact | +8613550822229 | duxiaobo2005@126.com | |
| Xue W Y, Student | Contact | +8615181958867 | 532995900@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Du X, Doctor | Mianyang Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaobo du | Recruiting | Mianyang | Sichaung | 621000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32864805 | Derived | Zhao Z, Wen Y, Liao D, Miao J, Gui Y, Cai H, Chen Y, Wei M, Jia Q, Tian H, Sun M, Zhang Y, Feng G, Du X. Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1900-e1908. doi: 10.1634/theoncologist.2020-0808. Epub 2020 Sep 28. |
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| 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 |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
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|
| S-1 plus Cisplatin concurrent radiotherapy | Other | Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~30 planning target volume times, Gross tumor volume of primary tumor60~66 Gray/28~33), synchronous chemotherapy S-1 70 mg/m2 1~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle. |
|
| Two years after adjuvant chemotherapy finished |
| 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 |