Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Device: Esophageal stent placement
- Registration Number
- NCT00826813
- Lead Sponsor
- Southeast University, China
- Brief Summary
More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
- Detailed Description
Esophageal cancer ranks as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The following preliminary clinical study in a single institute has demonstrated longer survival time, better quality of life and less restenosis of the stent than whose with the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- Histologically confirmed primary cancer of esophagus,
- Must be dysphagia caused by esophageal cancer,
- Without esophageal fistulas,
- Must be an inpatient,
- Life expectancy is over 6 months
- Esophageal fistulas,
- Tracheal compression with symptoms,
- WBC <2000/mm3 and Platelet count <50,000/mm3,
- Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description stenting Esophageal stent placement The conventional esophageal stent or 125I radiation stent is placed in the patients with dysphagia who are enrolled to the study.
- Primary Outcome Measures
Name Time Method Overall survival Death of the patient
- Secondary Outcome Measures
Name Time Method Quality of life 3, 6, 12 months Restenosis of the stent 3, 6, 12 months Dysphagia relief 3, 6, 12 months
Trial Locations
- Locations (1)
#87 Dingjiaqiao Road
🇨🇳Nanjing, Jiangsu, China