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This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjuvant chemoradiotherapy | Experimental | Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy. |
|
| adjuvant radiotherapy | Experimental | Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant radiotherapy | Radiation | Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The overall survival | To evaluate the 3 years overall survival of two groups. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | To evaluate the 3 years disease-free survival of two groups. | 3 years |
| Adverse Events | Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weimin Mao, MD. | Contact | +86-571-88122032 | maowmzj1218@163.com | |
| Yaping Xu, MD. | Contact | +86-571-88122082 | xuyaping1207@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Weimin Mao, 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 |
|---|---|
| D018714 | Radiotherapy, Adjuvant |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D011878 | Radiotherapy |
| D043823 | Taxoids |
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| Adjuvant radiotherapy | Radiation | adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy. |
|
| Paclitaxel and carboplatin | Drug |
|
| 1 year |
| Scores of Quality of life | Assess the quality of life based on FACT-E | 1 year |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |