Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy Versus Gemcitabine Alone in Patients With Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Survival
研究概览
简要总结
For patients with unresectable locally advanced pancreatic cancer, the combined use of external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely recognized as the most effective chemoradiotherapy approach.But most patients succumb to local recurrence and metastasis after treatment, and the prognosis remains poor On the basis of the development and superiority of the interstitial brachytherapy and the radiosensitizing effect of gemcitabine, we performed a clinical study to explore the interaction of improved I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven
- •locally advanced pancreatic adenocarcinoma stage
- •No systemic metastases
- •Age between 18-75
- •Karnofsky-Performance Status equal to, or greater than 70 %
- •At least a 2-dimensionally measurable tumor lesion
- •Adequate renal and liver function
- •Written consent statement
- •Patients' compliance and geographical proximity
- •Life expectancy equal to or greater than 3 months
排除标准
- •Serious psychological disease
- •Pregnancy and inadequate or not secure contraception or breastfeeding women
- •Other previous malignant disease in the past two years
- •Serious systemic concomitant diseases, excluding participation in a trial
- •Other experimental treatment during or within 6 weeks prior to this trial (including chemotherapeutic medicine or immune-therapies)
- •Every other condition or therapy assessed by the physician as an eventual risk for the patient or restricting the aims of the trial
- •Distant metastasis
研究组 & 干预措施
A
干预措施: gemcitabine (Drug)
B
干预措施: 125I brachytherapy PLUS gemcitabine (Other)
结局指标
主要结局
Survival
时间窗: 2 years after the inclusion of the last patient
次要结局
- response rate, clinical benefit response, and safety(2 month after the treatment finished)