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

NCT ID: NCT07211815

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-06-01

Brief Summary

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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.

Conditions

Primary Liver Cancers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Gamma Knife Treatment Group

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.

No interventions assigned to this group

Accelerator Treatment Group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chifeng Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chifeng Tumor Hospital

Chifeng, Inner Mongolia, China

Countries

China

Central Contacts

Jiarui zhang

Role: CONTACT

rad_zhangjiarui@163.com

15049640955

Facility Contacts

Jiarui Zhang

Role: primary

rad_zhangjiarui@163.com

+8615049640955

Other Identifiers

CFSZLYY - FLK - 2025 - 001

Identifier Type: -

Identifier Source: org_study_id