Prospective Randomized Clinical Trial for no Inferiority With Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery (TEM) Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Local recurrence
研究概览
简要总结
The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The technique involves a low anterior rectal or colo-anal resection, very often associated with a protective stoma or abdominal-perineal resection with permanent colostomy. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas consider TEM to be the technique of choice. However the treatment of T2 rectal cancers remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant reduction in local recurrence and an increase in survival.
Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3 N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve effective results in terms of local recurrence similar to radical surgery (TME).
OBJECTIVES:
Primary: To compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and TEM and in patients treated with conventional radical surgery (TME).
Secondary: To analyse the 3-year survival results in patients treated with CT/RT.
Methodology: Multicenter clinical trial in a calculated sample of 173 patients.
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
- •Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the EUS.
- •Preoperative staging by EUS and pelvic MRI of T2 or T3 superficial, N
- •In case of disparity, the higher staging is considered as the definitive diagnosis.
- •Tumours equal to or less than 4 cm of diameter maximum measured using colonoscopy, EUS or MRI. We use the highest score on both scores.
- •ASA score III or less.
- •Absence of distance metastasis as shown on abdominal CT.
排除标准
- •Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N
- •Presence of distance metastasis.
- •Synchrony with other colorectal adenocarcinomas.
- •Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
- •Patients with intolerance of preoperative chemotherapy or radiotherapy.
- •Refusal to sign informed consent to enter the study.
研究组 & 干预措施
Chemoradiotherapy+TEM
Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 6-8 weeks, transanal endoscopic microsurgery (TEM)is done
干预措施: Capecitabine (Xeloda) (Drug)
Chemoradiotherapy+TEM
Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 6-8 weeks, transanal endoscopic microsurgery (TEM)is done
干预措施: 50.4 Gy (Radiation)
Chemoradiotherapy+TEM
Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 6-8 weeks, transanal endoscopic microsurgery (TEM)is done
干预措施: Transanal Endoscopic Microsurgery (Procedure)
Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer
干预措施: Total Mesorectal Excision (Procedure)
结局指标
主要结局
Local recurrence
时间窗: 2 years
To analyse the results for local recurrence after 2 years in patients treated with preoperative chemoradiotherapy and TEO, with patients treated with conventional radical surgery (TME).
次要结局
未报告次要终点
研究者
Xavier Serra-Aracil
Medical Doctor
Corporacion Parc Tauli