A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
18 Years
70 Years
Both
Esophageal Carcinoma
Trial Information
A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
tumour local control rate
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Lvhua Wang, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Hospital, Chinese Academy of Medical Science
Authority:
China: Food and Drug Administration
Study ID:
CMNa-ESO-01-2007
NCT ID:
NCT00642239
Start Date:
April 2008
Completion Date:
December 2009
Related Keywords:
- Esophageal Carcinoma
- Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Diseases
- Esophageal Neoplasms
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