Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients: A Case-matched Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 477
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.
详细描述
Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology is confirmed as rectal adenocarcinoma.
- •18 to 75 years old.
- •Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.
- •The anus couldn't be retained after TME.
- •Almost-cCR or cCR recurrence during observation.
排除标准
- •Patients were unable to tolerate the operation.
- •Preoperative stage: T4b or progress during the treatment.
- •HIV infection stage or chronic hepatitis B.
- •Active clinical severe infections.
- •Evil liquid state or decompensation of organ function.
- •Other malignant tumor history in five years.
- •Other primary carcinoma.
- •Unstable condition and incompliance of the patient
研究组 & 干预措施
transanal surgery
To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm.
The intestinal wall was sutured to ensure the integrity of the bowel.
干预措施: transanal surgery (Procedure)
transanal surgery
To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm.
The intestinal wall was sutured to ensure the integrity of the bowel.
干预措施: Preoperative chemoradiotherapy (Drug)
Miles surgery
According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.
干预措施: Miles surgery (Procedure)
Miles surgery
According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.
干预措施: Preoperative chemoradiotherapy (Drug)
结局指标
主要结局
PFS
时间窗: three years
The progression-free survival of 3 years
OS
时间窗: three years
3 years of overall survival time
次要结局
- carcinoembryonic antigen（CEA）(every 3 months,for 2 years)
- carbohydrate antigen 19-9（CA-199）(every 3 months,for 2 years)
- International Index of Erectile Function-15(every 3 months ,for 2 years)
- International prostate symptom score(every 3 months ,for 2 years)
- Female sexual function index(every 3 months,for 2 years)
- Wexner incontinence score(every 3 months,for 2 years)
- QOL(every 3 months,for 2 years)
研究者
Zhang Rui
Head of colorectal surgery,clinical professor
Liaoning Tumor Hospital & Institute