Colorectal Cancer Liver Metastasis
Conditions
Keywords
colorectal cancer, liver metastasis, Radiofrequency Ablation, chemotherapy, target therapy
Brief summary
To date no prospective trials have been completed that demonstrated whether RFA is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.
Interventions
DEVICERadiofrequency Ablation (RFA)
The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue
chemotherapy ± target therapy
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
All patients must meet the following criteria: Patients must have incurable CRLM Patients must have no more than 10 liver metastases (LMs) remaining after surgical resection, with diameter less than 5cm Patients is medically eligible to receive RFA, as determined by the MDT (multidisciplinary team) Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Age \> 18 years Subject life expectancy \> 3 months Platelets \> 100×103/mm3 Total bilirubin \<1.5mg/dl Creatinine level \< 2.0 mg/dl All patients must sign an informed consent form
Exclusion criteria
The CRLM is amenable to curative surgical therapy Uncorrectable coagulopathy Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival Current or planned treatment with any experimental chemotherapy or target drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival in subjects receiving RFA plus chemotherapy ± target therapy compared to chemotherapy ± target therapy alone was assessed from the date of study entry until death from the disease. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| The differences in the incidence or severity of adverse events in the RFA plus chemotherapy ± target therapy arm compared to the chemotherapy ± target therapy only arm were was assessed by of complications after therapy. | 30 days post therapy |
Countries
China
Contacts
Primary ContactJianmin Xu, PhD
Outcome results
None listed