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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | RFA plus chemotherapy ± target therapy |
|
| Arm B | Active Comparator | chemotherapy ± target therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation (RFA) | Device | The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue |
| Measure | Description | 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 |
| Measure | Description | 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Xu, PhD | Contact | +86-13501984869 | xujmin@aiiyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Xu, PhD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hosptial, Fudan University | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| chemotherapy ± target therapy | Drug | chemotherapy ± target therapy |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |