Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
NCT ID: NCT03127072
Last Updated: 2017-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2017-04-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
RFA plus chemotherapy ± target therapy
Radiofrequency 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
chemotherapy ± target therapy
Arm B
chemotherapy ± target therapy
chemotherapy ± target therapy
chemotherapy ± target therapy
Interventions
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Radiofrequency 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
chemotherapy ± target therapy
Eligibility Criteria
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Inclusion 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
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
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xu jianmin
Prof.
Principal Investigators
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Jianmin Xu, PhD
Role: STUDY_CHAIR
Fudan University
Locations
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Zhongshan hosptial, Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RFACRLM
Identifier Type: -
Identifier Source: org_study_id
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