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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Sun Yat-sen University | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
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Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase Ⅲ multicenter clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response (CCR) after neoadjuvant radiochemotherapy for resectable locally advanced esophageal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive Radiochemotherapy | Experimental | Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day. |
|
| Neoadjuvant Radiochemotherapy | Active Comparator | Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definitive Radiochemotherapy | Combination Product | Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-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 |
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Qian, PHD & MD | Contact | +862223341405 | qiankeyu1984@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ping Wang, PHD & MD | Department of Radiation Oncology, Tianjin Medical University Cancer Hospital | Study Chair |
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| Neoadjuvant Radiochemotherapy | Combination Product | 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. |
|
grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular. |
| 5 years |
| Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer | In the group of neoadjuvant radiochemotherapy plus surgery, we will compare the pathological diagnosis between specimens of endoscopic biopsy after neoadjuvant treatment and surgically resected. | 3 years |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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