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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Concurrent radiochemotherapy and placebo |
|
| 1 | Experimental | concurrent radiochemotherapy and Sodium Glycididazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumour local control rate | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| survival rate | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lvhua Wang, Doctor | Contact | 86-10-87788503 | wlhwq@yahoo.com | |
| Jun Liang, Doctor | Contact | 86-10-87788503 | lj139117@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lvhua Wang, Doctor | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100036 | China |
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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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| Sodium Glycididazole | Drug | 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. |
|
|
| Cancer Center of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| Zhongshan Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | 100021 | China |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |