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| ID | Type | Description | Link |
|---|---|---|---|
| 2011C13039-2 | Other Grant/Funding Number | Zhejiang Provincial Science and Technology Major Projects |
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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Fudan University | OTHER |
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The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.
Esophageal cancer is one of the most difficult malignancies to cure. Surgical resection remains the primary treatment for localized esophageal cancer. It increases the chances of cure and alleviates the symptoms of dysphagia compared with nonoperative methods. Advances in surgical techniques and equipments have made minimally invasive esophagectomy (MIE) more popular and wider application since 1990s. During the past two decades, MIE has progressively been accepted as an alternative treatment for esophageal cancer around the world. The prognosis has some improvement on account of these significant advances in surgical techniques and perioperative management, But the prognosis of patients with locally advanced esophageal cancer remains rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.
Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. It should be noticed that only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2 years, which may be not perfect to evaluate the effect of this combined therapy for this tumor type.
Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine and cisplatin-based neoadjuvant chemoradiotherapy. Then we are to carry out a clinical trial to investigate the effect of this multidisciplinary therapy, by comparing neo-adjuvant chemoradiotherapy followed by Mckeown MIE versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE |
|
| Radical Chemoradiotherapy | Active Comparator | only Radical Chemoradiotherapy |
|
| Mckeown MIE | Active Comparator | only Mckeown MIE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE | Procedure | Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | 1 years | |
| Disease free survival | 5years | |
| Overall survival rate | 3years | |
| Overall survival rate | 5years |
| Measure | Description | Time Frame |
|---|---|---|
| the opportunity of MIE after neo-adjuvant chemoradiotherapy | Criteria:Response Evaluation Criteria in Solid Tumors,RECIST | 4 weeks after completion of radiotherapy |
| Side effects of neo-adjuvant chemoradiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng chu Zhu, professor | Contact | 86-576-85199876 | zhucc669266@163.com | |
| min Kong, master | Contact | 86-576-85199101 | kongm@enzemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng chu Zhu, professor | Taizhou Hospital | Study Chair |
| Bao fu Chen, professor | Taizhou Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thaizhou Hospital | Recruiting | Linhai | Zhejiang | 317000 | China |
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| Cisplatin | Drug | only Radical Chemoradiotherapy |
|
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| Mckeown MIE | Device | only Mckeown MIE using thoracoscopy and laparoscopy |
|
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Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0
| 2 weeks after completion of radiotherapy |
| Duration of surgery | The time between the start of surgery until the end of surgery | Intraoperative |
| Quantity of bleeding | The amount of bleeding during surgery | Intraoperative |
| number of lymph nodes retrieved | The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area | Intraoperative |
| Days of postoperative stay | Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days | The duration of hospital stay after surgery, an expected average of 12 days |
| Rate of Operative Complication | 30 days after surgery |
| Mortality of perioperation | 30 days after surgery |
| 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 |
|---|---|
| D002945 | Cisplatin |
| D000077235 | Vinorelbine |
| D013906 | Thoracoscopy |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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