A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT03416803|
Recruitment Status : Unknown
Verified January 2018 by Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting
First Posted : January 31, 2018
Last Update Posted : February 5, 2018
- To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis.
- To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with HCC with lymph node metastasis under the guidance of a microRNA prediction model.
|Condition or disease||Intervention/treatment||Phase|
|Lymph Node Metastasis Hepatocellular Carcinoma Radiotherapy||Radiation: Radiotherapy||Not Applicable|
First, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as HCC .
Then，performing the detection of miR-145, miR-31 and miR-92a by using the HCC lymph node metastasis microRNA correlation prediction model established in our previous study. The patients are judged as high risk of lymph node metastasis and low risk Patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups.
Last, Patients enrolled in the treatment group were treated with radiotherapy and followed up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prediction of Lymph Node Metastasis in Hepatocellular Carcinoma and the Study of Individualized Radiotherapy|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Patients in the experimental group, who were at high risk for lymph node metastasis, underwent radiotherapy in the lymphatic drainage area. Radiotherapy was started in lymphatic drainage areas about 1 month after HCC surgery. The range of radiotherapy was hepatic portal area, pancreas circumference, celiac trunk and abdomen Around the aortic lymph drainage area, the dose of radiation 45Gy, conventional segmentation.
No Intervention: Blank control
Patients in the control group , who were at high risk for lymph node metastasis，were followed up.
- 2-year overall survival [ Time Frame: The outcome measures are assessed up to 2 years. ]The therapeutic effects are mainly evaluated by the 2-year overall survival.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416803
|Contact: Zhaochong Zeng, Phdemail@example.com|
|Contact: Zuolin Xiang, Phdfirstname.lastname@example.org|
|180 Fenglin Road||Recruiting|
|Shanghai, China, 200032|
|Contact: Zhaochong Zeng, Phd 86-13817076800 email@example.com|
|Principal Investigator:||Zhongshan Hospital, PhD||Fudan University, Shanghai,China|