KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 358
- 试验地点
- 14
- 主要终点
- Disease-free survival
研究概览
简要总结
This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of mid or low rectum
- •Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)
- •Clinical stage T1-3N1or2 on MRI
- •Clinical stage cT3N0 (or depth of perirectal invasion by tumor >5mm on MRI)
- •Suspicious of circumferential invasion on MRI (or circumferential margin <1mm)
- •ECOG performance status of 0-2
- •ASA grade ≤ 3
- •An informed consent has been signed by the patient
排除标准
- •Upper rectal cancer
- •Clinical stage T1or2N0 on MRI
- •Clinical stage T4Nany on MRI
- •Clinical stage TanyNanyM1 by image or histology
- •The patient received chemotherapy or radiotherapy during the past 6 months
- •The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
- •The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
- •Pregnant of breastfeeding women
- •The patient who participate in another clinical trial, or receives any drug for the trial
- •Uncontrolled peripheral neuropathy (more than grade 2)
- •Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
- •Active gastrointestinal bleeding
- •Patients with an active infection, which needs antibiotic therapy, during the randomization period
研究组 & 干预措施
Adjuvant chemotherapy
After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
干预措施: Chemotherapy (Drug)
Consolidation chemotherapy
After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3 years
The rates of patients who survive without recurrence
Pathologic complete response
时间窗: 2 years
Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)
次要结局
- Peripheral neuropathy(3 years)
- Radiotherapy-related complications(2 years)
- R0 resection(2 years)
- Tumor response rate(2 years)
- Postoperative complications(2 years)
研究者
Suk-Hwan Lee
Professor
Kyung Hee University Hospital at Gangdong