A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
- Registration Number
- NCT00642239
- Lead Sponsor
- Shandong Luye Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo Concurrent radiochemotherapy and placebo 1 Sodium Glycididazole concurrent radiochemotherapy and Sodium Glycididazole
- Primary Outcome Measures
Name Time Method tumour local control rate 6 weeks
- Secondary Outcome Measures
Name Time Method survival rate one year
Trial Locations
- Locations (4)
Cancer Center of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China