A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma - Full Text View

Sponsored by:	Shandong Luye Pharmaceutical Co., Ltd.
Information provided by:	Shandong Luye Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00642239

Purpose

This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Condition	Intervention	Phase
Esophageal Carcinoma	Drug: placebo Drug: Sodium Glycididazole	Phase IV

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma

Further study details as provided by Shandong Luye Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

tumour local control rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

survival rate [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator 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.
1: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642239

Contacts

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

Locations

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
Beijing Cancer Hospital	Recruiting
Beijing, China, 100036
Contact: Bo Xu, Doctor 8610-88196170 fangliaoxubo@vip.sina.com
Principal Investigator: Bo Xu, Doctor
Zhongshan Hospital of Fudan University	Recruiting
Shanghai, China, 200032
Contact: Fengying Wang, Doctor 8621-64160820
Principal Investigator: FengYing Wang, 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

Sponsors and Collaborators

Shandong Luye Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:	Lvhua Wang, Doctor	Cancer Hospital, Chinese Academy of Medical Science
Principal Investigator:	Lvhua Wang, Doctor	Cancer Hospital, Chinese Academy of Medical Science

More Information

Responsible Party:	Cancer Hospital of Chinese Academy of Medical Sciences ( Lvhua Wang/Professor )
Study ID Numbers:	CMNa-ESO-01-2007
Study First Received:	March 21, 2008
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00642239
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shandong Luye Pharmaceutical Co., Ltd.:

Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma

Study placed in the following topic categories:

Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Squamous cell carcinoma
Carcinoma
Epidermoid carcinoma
Digestive System Diseases

Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Esophageal neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009