LOTCOL Study: Local Treatment of Colo-rectal Liver Met
关键词
抽象
日期
| 最后验证: | 12/31/2016 |
| 首次提交: | 05/02/2013 |
| 提交的预估入学人数: | 05/22/2013 |
| 首次发布: | 06/03/2013 |
| 上次提交的更新: | 01/05/2017 |
| 最近更新发布: | 01/08/2017 |
| 实际学习开始日期: | 04/30/2013 |
| 预计主要完成日期: | 11/30/2016 |
| 预计完成日期: | 11/30/2016 |
状况或疾病
干预/治疗
Procedure: Cheomotherapy and local treatment
Drug: Cheomotherapy
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Cheomotherapy and local treatment Standard chemotherapy + local treatment | Procedure: Cheomotherapy and local treatment Radiofrequency ablation Microwave ablation Radiation therapy |
| Placebo Comparator: Cheomotherapy Standard chemotherapy | Drug: Cheomotherapy |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Histologically verified adenocarcinoma of colon or rectum - Ambulatory with an ECOG performance status 0-2 - At least 18 years of age - Non-resectable liver metastases - Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients - 1-4 liver metastases with largest diameter of up to 6 cm on CT-scan - Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm - The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt) - Laboratory values as the following: - ANC ³ 1.5 x 109/L - Platelets ³ 100 x 109/L - Hb ³ 9g/dL - Creatinine £ 2x upper limit of normal - Bilirubin < 2.0x the upper limit of normal - ASAT and ALAT £ 5x the upper limit of normal - Albumin levels > 30 g/L - INR<1.3 - Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations Exclusion Criteria: - Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt) - History of prior metastatic disease the last 3 years - History of CNS or bone metastases - Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia - Largest liver mets >6 cm, more than 4 liver lesions >4 cm - Pulmonary mets>3 cm - Lymph node mets >2.5 cm - Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment - Any reason why, in the opinion of the investigator, the patient should not participate. |
结果
主要结果指标
1. Overall survival from time of randomization [6 months]
