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

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

Detailed Description
-----------------
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.

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

Conditions
-----------------
Esophageal Carcinoma

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: Sodium Glycididazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent photographically and histologically proven thoracic esophageal squamous carcinoma stages 2a-3, and stage 4 with only supraclavicular lymph nodes metastasis defined by AJCC(2002) radiochemotherapy indication measurable tumor adequate hematologic, hepatic and renal function Karnofsky performance status ≥70 age more than 18years and less than 70 years Exclusion Criteria: pregnancy and lactation significant neurologic disease severe liver and renal malfunction,and Significant medical illness previous chemotherapy, radiotherapy or immunotherapy esophagus hemorrhage and esophagus perforation features

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Concurrent radiochemotherapy and placebo | Drug: placebo<br>* placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.<br>|
| Experimental: 1<br>concurrent radiochemotherapy and Sodium Glycididazole | Drug: Sodium Glycididazole<br>* 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.<br>* Other names: CMNa;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumour local control rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma