Condition or disease | Intervention/treatment | Phase |
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Radiotherapy Microwave Ablation Liver Metastases Colorectal Cancer | Radiation: stereotactic radiotherapy Other: microwave alabation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | non-randomized trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Efficacy of Stereotactic Radiotherapy and Microwave Ablation for Liver Metastases From Colorectal Cancer: a Prospective Multicenter Cohort Study |
Actual Study Start Date : | June 3, 2019 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | May 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Stereotactic radiotherapy
In this study, the liver metastases were treated with Cyberknife stereotactic radiotherapy.Using multimodal image fusion to outline the target area.According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 90-120 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 70-90 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
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Radiation: stereotactic radiotherapy
The liver metastases were treated with Cyberknife stereotactic radiotherapy.Using multimodal image fusion to outline the target area.According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 90-120 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 70-90 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
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Experimental: Microwave ablation therapy
In this study, 3D printing template was used to assist microwave ablation.For those whose lesions are directly smaller than 5.0cm, the ablation time is about 10 min and 15 min, and the ablation time is more than 15min in patients larger than 5.0cm.
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Other: microwave alabation
The colorectal cancer patients with liver metastases will receive microwave ablation.3D printing template was used to assist microwave ablation.For those whose lesions are directly smaller than 5.0cm, the ablation time is about 10 min and 15 min, and the ablation time is more than 15min in patients larger than 5.0cm.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The main organ function can tolerate stereotactic radiotherapy / microwave ablation, liver function child-pugh A or B, no severe hypertension, diabetes and heart disease. That is, within 14 days of random examination, the relevant test indexes meet the following requirements:
Exclusion Criteria:
Contact: Junjie U Wang, MD | +8682264910 ext +8682264910 | junjiewang_edu@sina.cn | |
Contact: Fei U Xu, M Med | +8618511866032 ext +8682264910 | xufeibysy@163.com |
China, Beijing | |
Beijing Ditan Hospital | Recruiting |
Beijing, Beijing, China, 100000 | |
Contact: Wei Li, MD | |
Peking University Third Hospital | Recruiting |
Beijing, Beijing, China, 100000 | |
Contact: Junjie Wang, Chairman +8682264910 junjiewang_edu@sina.cn | |
Contact: Fei Xu +8618511866032 xufeibysy@163.com | |
Principal Investigator: Junjie Wang, Chairman | |
Sub-Investigator: Fei Xu | |
Sub-Investigator: Fuxin Guo | |
The fifth medical center of PLA general hospital | Recruiting |
Beijing, Beijing, China, 100000 | |
Contact: Xuezhang Duan, director +8613621386161 13621386161@163.com | |
Principal Investigator: Xuezhang Duan | |
Sub-Investigator: Hui Xie | |
Sub-Investigator: Jing Sun | |
China, Guangxi | |
Guangxi ruikang hospital | Recruiting |
NanNing, Guangxi, China, 530000 | |
Contact: ZuPing Lian, M Med | |
China, Hunan | |
Hunan Aerospace Hospital | Recruiting |
Changsha, Hunan, China, 410205 | |
Contact: Xian Xu, MD | |
China, Shandong | |
Tengzhou Central People's Hospital | Recruiting |
Tengzhou, Shandong, China, 277599 | |
Contact: Kaixian Zhang, director +8613563200960 kaixianzhang@aliyun.com | |
Principal Investigator: Kaixian Zhang, director |
Study Chair: | Junjie U Wang, MD | Peking University Third Hospital | |
Study Director: | Fei U Xu, M Med | Peking University Third Hospital | |
Principal Investigator: | Xuezhang Duan, MD | Beijing 302 Hospital | |
Principal Investigator: | Kaixian Zhang, MD | Tengzhou Central People's Hospital | |
Principal Investigator: | Wei Li, MD | Beijing Ditan Hospital | |
Principal Investigator: | Hui Xie, MD | Beijing 302 Hospital | |
Principal Investigator: | Zuping Lian, MD | Guangxi Ruikang Hospital | |
Principal Investigator: | Xian Xu, M Med | Hunan Aerospace Hospital | |
Principal Investigator: | Fuxin Guo, MD | Peking University Third Hospital | |
Principal Investigator: | Jing Sun, M Med | Beijing 302 Hospital |
Tracking Information | |||||||||||||||||||||||||||||||
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First Submitted Date ICMJE | May 21, 2019 | ||||||||||||||||||||||||||||||
First Posted Date ICMJE | May 28, 2019 | ||||||||||||||||||||||||||||||
Last Update Posted Date | July 19, 2019 | ||||||||||||||||||||||||||||||
Actual Study Start Date ICMJE | June 3, 2019 | ||||||||||||||||||||||||||||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||
Change History | |||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||
Brief Title ICMJE | Clinical Efficacy of Stereotactic Radiotherapy and Microwave Ablation for Liver Metastases From Colorectal Cancer. | ||||||||||||||||||||||||||||||
Official Title ICMJE | Clinical Efficacy of Stereotactic Radiotherapy and Microwave Ablation for Liver Metastases From Colorectal Cancer: a Prospective Multicenter Cohort Study | ||||||||||||||||||||||||||||||
Brief Summary | Data of 100 colorectal cancer patients with liver metastases who received stereotactic radiotherapy of Cyberknife or microwave ablation in the multicenter of the research group from June 2019 to May 2021 were collected, as well as follow-up data.To evaluate the clinical efficacy of stereotactic radiotherapy and microwave ablation in liver metastases.In addition, the local control rate and side effects of stereotactic radiotherapy and microwave ablation in the treatment of liver metastases were explored, and the efficacy and safety of different doses of stereotactic radiotherapy were determined. | ||||||||||||||||||||||||||||||
Detailed Description |
In the study,data of 100 colorectal cancer patients with liver metastases who received Cyberknife stereotactic radiotherapy or microwave ablation in the multi-center of the research group from June 2019 to May 2021 were collected, as well as follow-up data.
2.1.3 CT scan 2.1.4 The range of tumors was determined by CT images. In principle, at the maximum level, the skin points corresponding to the vertical center of the tumor are the marker points of the locating needle. At the same time, the center of the tumor was taken as the origin point, and the longitudinal and transverse cross lines were drawn on the patient's body surface. Roughly delineate the range of tumors according to CT in body surface 2.2 Surgery and intraoperative optimization 2.2.1 Posture reduction and fixation of patients 2.2.2 Oxygen inhalation, ECG and blood pressure monitoring 2.2.3 Installation of 3D Printing Planar Coordinate Template Fixer 2.2.4 Routine disinfection, cave towel laying, local infiltration anesthesia, fixing 3D printing plane coordinate template according to the range of tumors determined by physical examination and preoperative plan, and adjusting the direction of plane template by protractor. 2.2.5 Puncture locating needle and puncture assistant fixing needle in 4 directions of tumor margin. 2.2.6The real-time CT 2.5mm image was imported into the navigation system, the puncture needle was marked, the puncture needle was simulated, and the resolution of the template was adjusted accurately. 2.2.7 Enhanced CT scan to determine the position and angle of template and pin accurately 2.2.8 Layer by layer puncture according to preoperative plan 2.2.9 After inserting the ablation antenna to the reserved position, scan CT again to confirm whether the puncture needle has reached the planned position. 2.2.10 Complete ablation of tumors as planned. 2.3Postoperative observation 2.3.1 With the assistance of the staff in the hospital, they will be transported back to the ward by flat car with their families. 2.3.2 Re-measurement of blood pressure and heart rate 2.3.3Observe whether there is bleeding or exudation at the puncture point after operation, and give hemostasis and pain relief if necessary. To evaluate the clinical efficacy of stereotactic radiotherapy and microwave ablation in liver metastases after these treatment.In addition, the local control rate and side effects of stereotactic radiotherapy and microwave ablation in the treatment of liver metastases were explored, and the efficacy and safety of different doses of stereotactic radiotherapy were determined. |
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Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: non-randomized trial Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||||||||
Estimated Enrollment ICMJE |
100 | ||||||||||||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||||||||||||||
Estimated Study Completion Date ICMJE | May 31, 2022 | ||||||||||||||||||||||||||||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||||||||||||||||||||||||
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Administrative Information | |||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT03963726 | ||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | BYSY-CKMA-LM | ||||||||||||||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Peking University Third Hospital | ||||||||||||||||||||||||||||||
Study Sponsor ICMJE | Peking University Third Hospital | ||||||||||||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Peking University Third Hospital | ||||||||||||||||||||||||||||||
Verification Date | May 2019 | ||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |