A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
NCT ID: NCT00642239
Last Updated: 2008-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
48 participants
INTERVENTIONAL
2008-04-30
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2
Concurrent radiochemotherapy and placebo
placebo
placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
1
concurrent radiochemotherapy and Sodium Glycididazole
Sodium Glycididazole
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.
Interventions
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placebo
placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
Sodium Glycididazole
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* significant neurologic disease
* severe liver and renal malfunction,and Significant medical illness
* previous chemotherapy, radiotherapy or immunotherapy
* esophagus hemorrhage and esophagus perforation features
18 Years
70 Years
ALL
No
Sponsors
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Shandong Luye Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Cancer Hospital of Chinese Academy of Medical Sciences
Principal Investigators
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Lvhua Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital Chinese Academy of Medical Science
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, China
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Bo Xu, Doctor
Role: primary
Mengzhong Liu, Doctor
Role: primary
Fengying Wang, Doctor
Role: primary
Lvhua Wang, Doctor
Role: primary
Jun Liang, Doctor
Role: backup
Other Identifiers
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CMNa-ESO-01-2007
Identifier Type: -
Identifier Source: org_study_id