跳至主要内容
临床试验/NCT03541304
NCT03541304已完成不适用

Efficacy and Toxicity of High Dose Radiotherapy Wich Concurrent Chemotherapy for the Treatment of Rectal Cancer

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
clinical response rate

研究概览

简要总结

While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.

After treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.

Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the Kaplan Meier Method and were compared by log-rank test.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from the anal verge;
  • pelvic radiation with a total dose ≥60Gy for the treatment of rectal cancer;
  • refused surgery as the initial treatment;
  • a complete set of clinical information and follow-up data.

排除标准

  • patients with terminal cancer who received palliative treatment;
  • patients received any treatment before admission to Sun Yat-sen University Cancer Center;
  • patients with second primary cancer.

结局指标

主要结局

clinical response rate

时间窗: evaluate 5 weeks after radiotherapy

the rate of clinical response in the whole group

次要结局

  • progression free survival(3 years)
  • short term and long term side effects(from the complete to 3 years after treatment)
  • overall survival(3 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan-hong Gao

Professor

Sun Yat-sen University

研究点 (1)

Loading locations...

相似试验

High Dose Radiotherapy for the Treatment of Rectal... | 临床试验