Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 40
- 主要终点
- Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after
研究概览
简要总结
Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.
详细描述
Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments. Local excision is a conservative alternative approach associated with low mortality and morbidity. The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer.
Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm, received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least, one fluoropyrimidine.
Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. In case of not confirmed pathological response following local excision, complementary rectal excision is required.
Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision) every 4 months for 2 years, then every 6 months for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •T2T3 low adenocarcinoma of the rectum
- •Tumour size =< 4cm
- •Less than 8 cm from the anal verge
- •No metastatic disease
- •Patient is at least 18 years of age
- •ECOG performance status score =< 2
- •Patient and doctor have signed informed consent
- •inclusion criteria : Residual clinical tumour size =< 2cm after radiochemotherapy
排除标准
- •T1, T4 tumour or anal sphincter invasion
- •Metastatic disease (M1)
- •Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy
- •History of cancer
- •Symptomatic cardiac or coronary insufficiency
- •Severe renal insufficiency
- •Peripheral neuropathy
- •Patient included in a trial
研究组 & 干预措施
1
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
干预措施: local rectal excision (Procedure)
2
Standard surgery
干预措施: total mesorectal excision (Procedure)
结局指标
主要结局
Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after
时间窗: 24 months
次要结局
- Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect(24 months)
- 5-year survival.(5 years)
- Quality of life (QLQ C30 - CR38)(at 0, 4, 8 and 12 months)