Total Neoadjuvant Therapy in Rectal Cancer Treatment
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- The rate of complete responses
研究概览
简要总结
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
详细描述
In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.
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
- •Have signed an approved informed consent form for the stud;
- •Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);
排除标准
- •rectal cancer recurrence;
- •Primary-multiple tumours of other localizations;
- •pelvis radiotherapy in anamnesis;
- •pregnancy, breastfeeding;
- •distant metastasis;
- •ECOG score 3-4
研究组 & 干预措施
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
干预措施: Concurrent Chemoradiotherapy (Combination Product)
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
干预措施: TME (Procedure)
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
干预措施: consolidation chemotherapy (Drug)
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
干预措施: adjuvant chemotherapy (Drug)
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
干预措施: Concurrent Chemoradiotherapy (Combination Product)
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
干预措施: TME (Procedure)
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
干预措施: adjuvant chemotherapy (Drug)
结局指标
主要结局
The rate of complete responses
时间窗: 3-6 months
The rate of pathological or clinical complete responses
次要结局
- Rate of R0-resections(immediately after surgery)
- Rate of compliance with radiotherapy and chemotherapy(6-8 months)
- rate of intraoperative and postoperative complications(0-30 days after surgery)
研究者
Rybakov Evgeny, MD
Head of Surgical department of oncoproctology
State Scientific Centre of Coloproctology, Russian Federation