Self-Expandable Esophageal Radiation Stent:a Multicentric Randomized Controlled Trial in Patients With Advanced Esophageal Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Overall survival and Median Survival
研究概览
简要总结
Esophageal cancer is common in some areas , ranking 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. Brachytherapy and esophageal self-expanding stent insertion have longer benefit. Stent insertion provides fastest improvement of dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent placement, complications in later setting occur and require further endoscopic treatment. Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.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. And a small-sample and unicentric prior clinical trial in the authors' institute certificated the novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life markedly. This current multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer.
详细描述
PURPOSE Rationale: Placing a stent in the esophagus may relieve the dysphagia caused by inoperable esophageal cancer rapidly and improve the quality of life . But recurrence of the neoplastic stricture remains a challenge after solitary stent placement. Brachytherapy is an option for palliation of the symptoms due to the esophageal strictures,however,it can not relieve the dysphagia rapidly. So a novel esophageal stent loaded with 125I seeds combines the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy.
Purpose: A small-sample and unicentric clinical trial in the authors' institute had certificated that a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life . This multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer.
OUTLINE: This is a multicentric, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.
- Arm II: Patients undergo placement of a conventional covered stent on day 1.
- Health-related quality of life is assessed at baseline, I, 3 and 6 months.
Condition :Esophageal Cancer Intervention (Procedure): Esophageal stent placement,dysphagia scores,complications of therapy,survival time of therapy Phase :Ⅲ
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endoscopically and histologically confirmed cancer of esophagus
- •Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level Ⅲ or level Ⅳ[STOOLER stand]
- •In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden
- •The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction
- •Patients with clear consciousness，Cooperation，ECOG performance status of 0,1 and 3
- •Informed consent: authorization and signature
排除标准
- •Poor general status,ECOG performance status of 4,
- •Dysphagia not caused by esophageal cancer,
- •Noncooperation or no authorization and signature.
- •The superior border of cancer higher than the seventh cervical vertebrae
- •Ulcerative esophageal carcinoma
- •Esophageal fistulas,
- •WBC less than 3000/mm3
- •Severe hepatic inadequacy or renal inadequacy,
结局指标
主要结局
Overall survival and Median Survival
时间窗: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement
次要结局
- Quality of life [ECOG performance status],Dysphagia grade [STOOLER stand],Change of the oesophageal cancer [ RECIST standard],Restenosis degree[esophagus visualization](Follow-up in intervals of 1, 3, 6, and 12 months after stent placement)
- Pathologic change of the cancer(Follow-up in intervals of 1, 3, 6, and 12 months after stent placement)
- Successful rate of stent placement(Follow-up in intervals of 1, 3, 6, and 12 months after stent placement)
研究者
Gao-Jun Teng
Director
Southeast University, China