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Trial Title:
A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
NCT ID:
NCT00642239
Condition:
Esophageal Carcinoma
Conditions: Official terms:
Carcinoma
Esophageal Neoplasms
Carcinoma, Squamous Cell
Conditions: Keywords:
Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
placebo
Description:
placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60
minutes.duration of treatment is 6 weeks.
Arm group label:
2
Intervention type:
Drug
Intervention name:
Sodium Glycididazole
Description:
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.
Arm group label:
1
Other name:
CMNa
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100036
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Xu, Doctor
Phone:
8610-88196170
Email:
fangliaoxubo@vip.sina.com
Investigator:
Last name:
Bo Xu, Doctor
Email:
Principal Investigator
Facility:
Name:
Cancer Center of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Mengzhong Liu, Doctor
Phone:
8620-83743371
Email:
lmz1955@163.com
Investigator:
Last name:
Mengzhong Liu, Doctor
Email:
Principal Investigator
Facility:
Name:
Zhongshan Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Fengying Wang, Doctor
Phone:
8621-64160820
Investigator:
Last name:
FengYing Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Lvhua Wang, Doctor
Phone:
86-10-87788503
Email:
wlhwq@yahoo.com
Contact backup:
Last name:
Jun Liang, Doctor
Phone:
86-10-87788503
Email:
lj139117@yahoo.com.cn
Investigator:
Last name:
Lvhua Wang, Doctor
Email:
Principal Investigator
Start date:
April 2008
Completion date:
December 2009
Lead sponsor:
Agency:
Shandong Luye Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shandong Luye Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00642239
