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A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00642239
Recruitment Status : Unknown
Verified May 2008 by Shandong Luye Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 25, 2008
Last Update Posted : May 14, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Drug: placebo Drug: Sodium Glycididazole Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
Study Start Date : April 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 2
Concurrent radiochemotherapy and placebo
Drug: 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.

Experimental: 1
concurrent radiochemotherapy and Sodium Glycididazole
Drug: 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 Name: CMNa




Primary Outcome Measures :
  1. tumour local control rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. survival rate [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642239


Contacts
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Contact: Lvhua Wang, Doctor 86-10-87788503 wlhwq@yahoo.com
Contact: Jun Liang, Doctor 86-10-87788503 lj139117@yahoo.com.cn

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100036
Contact: Bo Xu, Doctor    8610-88196170    fangliaoxubo@vip.sina.com   
Principal Investigator: Bo Xu, Doctor         
China, Guangdong
Cancer Center of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Mengzhong Liu, Doctor    8620-83743371    lmz1955@163.com   
Principal Investigator: Mengzhong Liu, Doctor         
China, Shanghai
Zhongshan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Fengying Wang, Doctor    8621-64160820      
Principal Investigator: FengYing Wang, Doctor         
China
Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Lvhua Wang, Doctor    86-10-87788503    wlhwq@yahoo.com   
Contact: Jun Liang, Doctor    86-10-87788503    lj139117@yahoo.com.cn   
Principal Investigator: Lvhua Wang, Doctor         
Sponsors and Collaborators
Shandong Luye Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Lvhua Wang, Doctor Cancer Hospital, Chinese Academy of Medical Science

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Responsible Party: Lvhua Wang/Professor, Cancer Hospital of Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00642239     History of Changes
Other Study ID Numbers: CMNa-ESO-01-2007
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008
Keywords provided by Shandong Luye Pharmaceutical Co., Ltd.:
Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Esophageal Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms, Squamous Cell