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

C

Chifeng Tumor Hospital

Status

Not yet enrolling

Conditions

Primary Liver Cancers

Study type

Observational

Funder types

Other

Identifiers

NCT07211815
CFSZLYY - FLK - 2025 - 001

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 0-1.
  • 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.

Exclusion criteria

  • 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.

Trial design

30 participants in 2 patient groups

Gamma Knife Treatment Group
Description:
Patients in this group receive body gamma knife radiotherapy. The treatment utilizes fixed radiation sources, and the treatment couch moves to each treatment target. A 50% isodose curve covers at least 95% of the Planning Target Volume (PTV), and this modality is applied for radiotherapy of locally advanced primary liver cancer.
Accelerator Treatment Group
Description:
Patients in this group receive radiotherapy with an accelerator (applying VMAT technology). Based on the tumor's location and surrounding organs at risk, beam angles and the number of fields are selected. The prescription dose curve covers 95% of the Planning Target Volume (PTV), and this method is used for radiotherapy of locally advanced primary liver cancer.

Trial contacts and locations

1

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Central trial contact

Jiarui zhang

Data sourced from clinicaltrials.gov

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