Curative Chemoradiotherapy Versus Radical Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. By prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal cancer 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A medical history of colorectal cancer
- •Pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins.
- •The treatment target is no evidence of disease (NED), including 3 cohorts:
- •A. Initial treatment (primary lesion + retroperitoneal LN oligometastasis); B. Postoperative retroperitoneal/paravascular LN oligometastase; C. Postoperative retroperitoneal/paravascular LN metastasis with other organ metastases (up to NED)
- •ECOG PS 0-2
- •Ability to follow the program during the study period
- •Signing written informed consent
排除标准
- •Retroperitoneal LN metastasis is above the level of the renal vein.
- •Unable to reach NED.
- •Previous pelvic radiotherapy, the field of irradiation overlaps with this time.
- •Pregnancy or breastfeeding women.
- •Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- •If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- •Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months
- •Organ transplantation requires immunosuppressive therapy
- •Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- •Subjects Blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets ≥ 100 × 109 / L; ALT, AST≤2.5 times normal upper limit; ALP≤2.5 times normal upper limit; serum total bilirubin <1.5 times normal upper limit; serum creatinine <1 times normal upper limit; serum albumin ≥30g/L
研究组 & 干预措施
radical chemoradiotherapy
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.
干预措施: chemoradiotherapy (Radiation)
radical surgery
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.
干预措施: lymphadenectomy (Procedure)
结局指标
主要结局
Progression-free survival
时间窗: From date of randomization until the date of disease progressed for any reason, assessed up to 5 years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS.
次要结局
- overall survival(From date of randomization until the date of death from any cause, assessed up to 5 years)
- local control rate(From date of randomization until the date of disease recurrece, assessed up to 5 years)