NCT00979680已完成3 期
Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
Institut du Cancer de Montpellier - Val d'Aurelle12 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2001年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 12
- 主要终点
- Sphincter preservation rate
研究概览
简要总结
This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
- •Tumor classified as EER UT2-UT3, whatever the nodal status
- •pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
- •Age 18 years or older
- •Informed and written consent
排除标准
- •T4 (proven invasion of sphincter)
- •Diffuse metastatic syndrome (no curative intent, short expected life span)
- •preoperative incontinence (non due to the tumor)
结局指标
主要结局
Sphincter preservation rate
时间窗: surgery
次要结局
- Tumor response according to rectal endo-echography(prior to surgery)
- operative mortality and morbidity(after surgery)
- anatomopathology margins (lateral and inferior)(after surgery)
- Disease-free survival(3 years)
- Overall Survival(4 years)
- Functional results (stoma closure, continence, manometry)(2 years)
- Local recurrence(3 years)
研究者
研究点 (12)
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