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

Esophageal Carcinoma Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00642239
• Other study ID #: CMNa-ESO-01-2007
• Status: Recruiting
• Phase: Phase 4
• First received: March 21, 2008
• Last updated: May 13, 2008
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2008
• Source: Shandong Luye Pharmaceutical Co., Ltd.
• Contact: Lvhua Wang, Doctor
• Phone: 86-10-87788503
• Email: wlhwq[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing
China	Cancer Center of Sun Yat-sen University	Guangzhou	Guangdong
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Luye Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumour local control rate		6 weeks	No
Secondary	survival rate		one year	No