Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy combined with surgical resection or radiofrequency ablation of liver lesions.
详细描述
Liver metastases are detected in 40-50% of patients diagnosed with colorectal cancer. Local treatments like surgical resection or radiofrequency ablation result in 5-year survival of 35%. However, relapse still occurs in 70% of patients. Stereotactic body radiotherapy (SBRT) has emerged as a valid treatment not only to provide excellent symptom palliation, but also is effective in local control of metastatic lesions and improves survival. The potential efficacy of SBRT as adjuvant radiotherapy in CRLM patients after surgical resection or radiofrequency ablation is still unknown.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven unresectable metastatic colorectal cancer (CRC)
- •Primary resection of colorectal cancer (CRC)
- •Age≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Absence of evidence of extra-hepatic diseases
- •1 to 3 liver metastases with an individual maximum diameter of up to 5 cm
- •Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed
- •Aspartate aminotransferase, alanine aminotransferase & alkaline phosphates must be ≤ 2.5 times of the upper limit of normal. Total bilirubin must be within the limit of normal.
- •Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm
- •Patients must provide verbal and written informed consent to participate in the study.
- •Absence of any severe pulmonary or cardiac diseases
排除标准
- •Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
- •Patients who are pregnant
- •Patients with severe organ dysfunction
- •History of liver radiotherapy
- •Unwillingness to participate or inability to comply with the protocol for the duration of the study
- •Participation in any investigational drug study within 3 months preceding the start of study treatment
- •Patients not suitable to take part in clinical trials judged by researches
研究组 & 干预措施
chemoradiotherapy
radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
干预措施: adjuvant SBRT (Radiation)
chemoradiotherapy
radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
干预措施: Chemotherapy (Drug)
chemotherapy
chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Disease free survival
时间窗: 2 years
Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival
次要结局
- Overall survival(5 years)
- Toxicities(2 years)
- Intrahepatic disease free survival(2 years)
研究者
Tao Zhang
Chief of Gastrointestinal Oncology Department
Wuhan Union Hospital, China