跳至主要内容
临床试验/NCT07211815
NCT07211815尚未招募不适用

Dosimetric Differences and Clinical Significance Analysis Between Body Gamma Knife and VMAT Radiotherapy for Primary Liver Cance

Chifeng Tumor Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Conformity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer

研究概览

简要总结

To fill in the "Brief Summary" field, you need to provide clear, easy-to-understand information about the study for patients, families, and healthcare providers. Here's a suggested summary:

This study compares the dosimetric features and clinical effects of body gamma knife and VMAT radiotherapy for locally advanced primary liver cancer. We retrospectively analyze 20 patients from Chifeng Tumor Hospital who cannot or refuse surgery. For each patient, we will develop both body gamma knife and VMAT radiotherapy plans. Then, we'll compare the dose distribution in the tumor target (including conformity index and homogeneity index) and the radiation exposure to organs at risk (such as the spinal cord, stomach, and liver). The goal is to find out which radiotherapy approach is more beneficial, so patients, families, and healthcare teams can better understand how this research supports treatment decisions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 18-75 years.
  • •Clinically or pathologically confirmed primary liver cancer; unsuitable for or - refusing surgery, with single tumor diameter ≤5 cm and ≤5 nodules.
  • •ECOG PS score 0-
  • •Liver function: Child-Pugh grade A or B.
  • •Prothrombin time (PT) < 4 seconds above the normal control range.
  • •No hepatic encephalopathy or moderate to large ascites.
  • •Renal and cardiopulmonary function basically normal.
  • •Gastroscopy findings: no severe esophageal varices or active peptic ulcer.
  • •Hemoglobin ≥90 g/L, WBC ≥3.0×10⁹/L, neutrophil ≥1.5×10⁹/L, platelet ≥40×10⁹/L.
  • •No obvious cachexia; life expectancy > 3 months.
  • •Not pregnant; no HIV or syphilis infection.
  • •Able to understand the study and sign informed consent.

排除标准

  • •History of portal hypertension, esophageal variceal bleeding, or related conditions.
  • •History of anti-RHCC treatment or spontaneous tumor rupture.
  • •Postoperative pathology indicates metastatic cancer or other primary cancers.
  • •Cerebrovascular accident within 6 months before enrollment.
  • •Severe lung disease; serum creatinine > 1.25×the upper normal limit.
  • •Poorly controlled acute or active infection; severe mental illness.
  • •Suspected systemic or local lymphadenopathy on imaging.
  • •Pregnant or lactating women; presence of other serious underlying diseases.
  • •Currently participating in other clinical trials; refusal to provide informed consent.

结局指标

主要结局

Conformity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer

时间窗: Within 1 month after completion of radiotherapy planning

Compare the conformity index (a dosimetric measure of how well radiation conforms to the target volume) between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.

次要结局

  • Gradient Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer(Within 1 month after completion of radiotherapy planning)
  • Homogeneity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer(Within 1 month after completion of radiotherapy planning)
  • Liver V20 Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer(Within 1 month after completion of radiotherapy planning)
  • Liver Mean Dose (Dmean) Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer(Within 1 month after completion of radiotherapy planning)
  • Liver V5 Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer(Within 1 month after completion of radiotherapy planning)

研究者

发起方
Chifeng Tumor Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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