A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 48
- Locations
- 4
- Primary Endpoint
- tumour local control rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2
Concurrent radiochemotherapy and placebo
Intervention: placebo (Drug)
1
concurrent radiochemotherapy and Sodium Glycididazole
Intervention: Sodium Glycididazole (Drug)
Outcomes
Primary Outcomes
tumour local control rate
Time Frame: 6 weeks
Secondary Outcomes
- survival rate(one year)