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

Luye Pharma Group

Status and phase: Unknown; Phase 4

Conditions: Esophageal Carcinoma

Treatments: Drug: placebo; Drug: Sodium Glycididazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642239

CMNa-ESO-01-2007

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

Concurrent radiochemotherapy and placebo

Treatment:

Drug: placebo

1

Experimental group

Description:

concurrent radiochemotherapy and Sodium Glycididazole

Treatment:

Drug: Sodium Glycididazole