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Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with localized carcinoma of the esophagus selected for nonsurgical treatment. The standard radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology. Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III, randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-dose | Experimental | concurrent chemoradiation:CT:DDP 25mg/m2 D1+docetaxel 25mg/m2 D1,Weekly for 5 wks;RT:60Gy/30F/6W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 75mg/m2 D1+docetaxel 75mg/m2 D1, Q3W |
|
| standard dose | Active Comparator | concurrent chemoradiation:CT:DDP 25mg/m2 D1+Docetaxel 25mg/m2 D1,Weekly for 5 wks;RT:50Gy/25F/5W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 5mg/m2 D1+Docetaxel75mg/m2 D1, Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensity modulated radiation therapy in both arms | Radiation |
| ||
| concurrent chemotherapy with radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| local control rate; relapse location; toxicity | 5 years | |
| radiation-related advent events | at least 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiao zheng, MD | Contact | 0086-571-88122078 | zhengxiao@medmail.com | |
| ming chen, PHD | Contact | 0086-571-88122068 | chenming@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Zheng, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Drug |
docetaxel plus cisplatin were used weekly in both arms |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D055585 |
| Physical Phenomena |