NCT05173610

Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma

Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma: Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Oligometastasis is a definition that has been described in the past in the 1990s, and in some patients, metastases are not extensive and are limited to a small number of metastases. The local ablative treatment for oligometastasis is not a new concept. In case of liver metastasis from colorectal cancer, long-term survival can be expected if the liver resection is performed. Effectiveness has been demonstrated in studies of adrenal and brain metastasis from lung cancer as well as lung metastasis from sarcoma. A recent non-randomized study reported that patients with oligometastasis improved treatment outcomes with aggressive treatment. This study demonstrated that local ablative treatment for oligometastasis showed better treatment outcomes than expected. Also, the long-term outcomes in SABR-COMET trial showed that the overall survival were increased by 22 months. So far, the standard treatment for metastatic disease is systemic chemotherapy. However, based on these results from studies, active local treatment for patients with oligometastasis is currently being performed in the clinic. In this study, we aimed to apply this concept to patients with hepatocellular carcinoma. To confirm the efficacy and safety of stereotactic radiotherapy in patients with oligometastasis hepatocellular carcinoma

Conditions

• Oligometastasis Hepatocellular Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiation: Stereotactic body radiotherapy (SBRT)	Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma. 1. Target delineation The GTV is set using diagnostic CT, MRI, PET-CT, etc. CTV is delineated including the microscopic range in GTV and internal margin using 4D-CT. The PTV is expanded by considering the uncertainty of the daily patient posture setting and placement. 2. Radiotherapy All patients are treated using 3D-CRT, IMRT, or VMAT. Total dose and fractionations will be determined depending on the location and character of the metastasized tumor. Detailed radiation prescriptions is summarized in the following paragraph. i. Liver: 48-60 Gy in 4 fractions ii. Lung: 45-60 Gy in 3-4 fractions iii. Brain: 27-30 Gy in 3-5 fractions iv. bone: 24-40 Gy in 3-5 fractions v. adrenal gland: 30-60 Gy in 3-8 fractions vi. other organ: depending on the clinicians' decision

Timeline

• Start date: 2021-09-28
• Primary completion: 2022-12-31
• Completion: 2023-09-27
• First posted: 2021-12-30
• Last updated: 2022-08-26

Locations

1 site across 1 country: South Korea