Phase II Study of Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced High-risk Rectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Evaluate MRI good response rate after the total neoadjuvant treatment
研究概览
简要总结
Short-course radiotherapy followed by consolidation chemotherapy has shown a better response rate when compared to chemoradiotherapy treatment.
In addition, recent studies have shown better tolerance with total neoadjuvant treatment, with induction or consolidation chemotherapy. Induction chemotherapy could reduce the size of the tumor, treat micrometastases early and allow treatment to start immediately (avoiding potential delays in waiting for radiotherapy). While consolidation chemotherapy allows longer waiting times for surgery, with higher response rates.
详细描述
Methods: This trial aim to evaluate induction treatment with CAPOX, followed by short-course radiotherapy consolidation chemotherapy with CAPOX. After 5-7 weeks, patients will be evaluate by MRI. Patients with incomplete clinical response will be referred to immediate surgery and patients with complete clinical response will be managed with "watch and wait" approach. Patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment.
The sample size was calculated according to Simon's optimal two-stage design. Accordingly, 21 patients must be included in each group during the first stage and 24 during the second stage. Treatment regimen will be considered effective if 9 or more patients show good response (final analysis), reaching 80% power with an alpha of 0.10 level of significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed adenocarcinoma of mid or low rectum
- •Locally advanced rectal cancer with one of the high-risk factors confirmed by high-resolution thin-slice Magnetic resonance image (3 mm) tumors extending to within 1 mm of, or beyond the mesorectal fascia; tumor extending 5 mm or more into perirectal fat; resectable cT4 tumors; lower third; nodal involvement; extramural vascular invasion
- •ECOG performance status of 0-2
- •An informed consent has been signed by the patient
排除标准
- •Upper rectal cancer
- •Metastatic disease
- •The patient received any previous therapy for colorectal cancer or another malignancy
- •Other malignant tumours within the last 5 years except cervical carcinoma in situ and basal cell carcinoma of the skin
- •Previous thromboembolic or haemorrhagic events within 6 months prior to registration
- •Patients with malabsorption syndrome or difficulties in swallowing
- •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)
结局指标
主要结局
Evaluate MRI good response rate after the total neoadjuvant treatment
时间窗: 16-20 weeks after SCRT
Good response rate is defined as the proportion of patients who reached mrTRG 1 or 2 and the absence of remote disease in the reevaluation period, with the denominator being the total number of patients who started total neoadjuvant treatment.
次要结局
- Overall survival(3 years)
- Describe the safety and tolerability of total neoadjuvant treatment.(1 year)
- Disease-free survival in 3 years(3 years)