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Definitive chemoradiotherapy(CRT) has been regarded as a standard of care for patients with unresectable locally advanced esophageal cancer. Patients who are sensitive to CRT can achieve significantly down staging. Whether this part of patients could benefit from further surgical treatment remains unknown. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive CRT versus neo-CRT plus radical resection in patients who achieved down staging after neo-CRT for stage T4NxM0 esophageal Cancer.
Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2), 1st/8th/15th/22nd day
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive Radiochemotherapy | Experimental | Concurrent Radiochemotherapy: Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day. |
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| Neoadjuvant Radiochemotherapy followed by surgery | Active Comparator | Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definitive Radiochemotherapy | Radiation | Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy | 5 years |
| Disease-free survival | Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Zhang, Doctor | Contact | +862223341405 | 839159994@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingsong Pang, Doctor | Department of Radiation Oncology, Tianjin Medical University Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Tianjin Medical University Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Neoadjuvant Radiochemotherapy followed by surgery | Procedure | Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later. |
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