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

Study Overview
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Brief Summary
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This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.

Detailed Description
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The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safty 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 104 cases.

Official Title
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A Perspective Random Trial of Sodium Glycididazole Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Drug: Sodium Glycididazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent prior to study entry Patients with ESCC in upper and middle thoracic segment（stage II-III）confirmed by imaging and pathology or cytology, which is unsuitable or refuse surgery; Capable for chemo-radiotherapy; The existence of measurable lesions; ECOG PS of 0 or 1 Possible semi-liquid diet; Expected lifetime≥3 months normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl normal hepatic funcion:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min normal cardiac function Subjects tumor tissue available for the relevant biomarker detection Exclusion Criteria: Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae) Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan Patients who have other malignant lesions, except curable skin cancer (non-melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years Primary lesions were multifocal Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles). Not esophageal squamous carcinoma confirmed by pathology or cytology History of active hepatitis Unable to comprehend the study requirement or who are not likely to comply with the study requirements Significant disease which, in the investigator's opinion, would exclude the patient from the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Glycididazole<br>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,T60Gy/30f,week 1-6 | Drug: Sodium Glycididazole<br>* Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.<br>|
| Placebo Comparator: Control Group<br>Placebo：dissolved in 100mlphysiological 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 6 weeks course.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, 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,T60Gy/30f,week 1-6 | Drug: Placebo<br>* Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 36 months | 
| Progression free survival |  | 36 months |