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The number of enrollment cases is too small.
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This is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with CMNa combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (pathologic Complete Response) will be done as defined in the protocol.
The primary end ponit of this study is pathological complete response.And the primary hypothesis is the CMNa will improve patholofical response rate and thus improve OS、DFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 40 cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Glycididazole | Experimental | Sodium Glycididazole:800mg/m2,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-4 Cisplatin:20 mg/m²,d1,week 1-4 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle. OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T40Gy/20f,week 1-4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Glycididazole | Drug | 800mg/m2,dissolved in 100ml physiological saline(Now with chef),ivgtt,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy, total 4 weeks course. |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic Complete Response | TRG-cited from Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, Roussel A, Jacob JH, Segol P, Samama G, Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Cancer, 73, 2680-2686, 1994. | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 36 months | |
| Disease-Free Survival | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu, Ph.D, M.D | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianfoshan Hospital of Shandong | Jinan | Shandong | 250117 | China | ||
| Shandong Cancer Hospital and Institute |
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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 |
|---|---|
| C000603632 | sodium glycididazole |
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| Jinan |
| Shandong |
| 250117 |
| China |
| Jining NO.1 People's Hospital | Jining | Shandong | 250117 | China |
| Liaocheng People Hospital | Liaocheng | Shandong | China |
| Qingdao Center Medical Group | Qingdao | Shandong | 250117 | China |
| Rizhao City People 's Hospital | Rizhao | Shandong | China |
| Fei Cheng People's Hospital | Tai’an | Shandong | 250117 | China |
| An Qiu People's Hospital | Weifang | Shandong | 250117 | China |
| The Fourth People's Hospitalof Zibo | Zibo | Shandong | 250117 | China |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |