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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
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The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.
The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials.
The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-adjuvant chemotherapy group | Experimental | Neo-adjuvant chemotherapy(cisplatin and paclitaxel):
Surgery: 2-3weeks after Neo-adjuvant chemotherapy
|
|
| Surgery alone group | No Intervention | Surgery: 2-3weeks after Neo-adjuvant chemotherapy
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin and paclitaxel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | 1 years and 3 years | |
| Disease free survival | 5 years | |
| assessment in perioperation-Removal rate (R0 resection rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yin Li, MD.&PhD. | Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100029 | 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 |
|---|---|
| C111043 | TP protocol |
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| Hunan Province Tumor Hospital | OTHER |
| Sun Yat-sen University | OTHER |
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|
The R0 resection rate of two groups |
| perioperative period |
| assessment in perioperation-Rate of Operative Complication | Complication rate after operation before discharge | perioperative period |
| assessment in perioperation-Mortality of perioperation | Mortality of perioperation 20 days before operation and 30 days after operation | perioperative period |
| assessment in perioperation-Days of Hospitalization | Days of Hospitalization after operation | perioperative period |
| assessment in perioperation-Thoracic Drainage | Thoracic Drainage days | perioperative period |
| assessment in perioperation-Quantity of bleeding | blood lose during operation | perioperative period |
| assessment in perioperation-Time of operation | the time from open thoracic cavity to the closure of the thoracic cavity | perioperative period |
| Quality of life | ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30 | 1 years |
| efficacy of neo-adjuvant chemotherapy--response rate | Criteria:Response Evaluation Criteria in Solid Tumors,RECIST. Pathologic Complete Response Rate. Pathologic Response Rate. | 1-4 days before operation |
| toxicities of neo-adjuvant chemotherapy | According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol | from chemotherapy to perioperative period |
| prognostic factors | prognostic factors for overall survival of both groups | 5 years |
| predictive factors | predictive factors for the efficiency of neo-adjuvant chemotherapy | 2 years |
| Beijing Cancer Hospital |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
| Sun Yat-sen Uniersity Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Anyang cancer hospital | Anyang | Henan | China |
| Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university | Zhengzhou | Henan | 450008 | China |
| Hunan Province Tumor Hospital | Changsha | Hunan | 410013 | China |
| Fudan Universitay Shanghai Cancer Center | Shanghai | Shanghai Municipality | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |