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Paclitaxel

Docetaxel

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Albumin-Bound Paclitaxel

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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 1-6 Cisplatin:20 mg/m²,d1,week 1-6 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,T\>40Gy/20f,week 1-\>5

Sodium Glycididazole 800mg/m2.Three times a week (once every other one day),before radiation therapy, total 5-6 weeks.

Sodium Glycididazole

Jinming Yu, Ph.D, M.D

This is a perspective, multicenter,single arm, open study to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.

The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safety of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%. The total sample size is 40 cases.

A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC

A Perspective Trial of Sodium Glycididazole Combined With Concurrent Chemoradiotherapy for Locally Recurrent Squamous Cell Esophageal Carcinoma

Shandong Cancer Hospital and Institute

president

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

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.

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.

A Trial of CMNa Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced ESCC

A Perspective Trial of Sodium Glycididazole Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma

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.

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

concurrent radiochemotherapy and Sodium Glycididazole

placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.

placebo

Sodium Glycididazole 700mg/m2 in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.

Lvhua Wang, Doctor

Jun Liang, Doctor

Bo Xu, Doctor

Mengzhong Liu, Doctor

Fengying Wang, Doctor

FengYing Wang, Doctor

This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Esophageal cancer is one of the most frequent causes of cancer death in the world. The most common type of esophageal cancer is squamous cell carcinoma (SCC) in China. Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%.

Sodium Glycididazole(CMNa) is a radiosensitive drug for hypoxic tumor cells. Clinical trials showed that CMNa can improve local control rate and survival rate of esophageal cancer. This study is going to confirm the efficacy and safety of CMNa in concurrent radiochemotherapy of radiotherapy and 5-FU+DDP for esophageal squamous carcinoma.

A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC	NCT02721576	Esophageal Neop...	Sodium Glycidid...	18 Years - 75 Years	Shandong Cancer Hospital and Institute
A Trial of CMNa Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced ESCC	NCT02721550	Esophageal Neop...	Sodium Glycidid...	18 Years - 75 Years	Shandong Cancer Hospital and Institute
A Trial of CMNa Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced ESCC	NCT02721550	Esophageal Neop...	Sodium Glycidid...	18 Years - 75 Years	Shandong Cancer Hospital and Institute
A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma	NCT00642239	Esophageal Carc...	placebo Sodium Glycidid...	18 Years - 70 Years	Shandong Luye Pharmaceutical Co., Ltd.
A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma	NCT00642239	Esophageal Carc...	placebo Sodium Glycidid...	18 Years - 70 Years	Shandong Luye Pharmaceutical Co., Ltd.

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