Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT arm | Experimental | Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation: Stereotactic body radiotherapy (SBRT) | Radiation | Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma.
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy (Overall survival) | The overall survival of patients from the start date of SBRT to either date of death or date of last follow up is evaluated | 2 year |
| Treatment efficacy (Disease free survival) | The disease free survival from the start date of SBRT to date of disease progression or date of death or date of last follow up is evaluated | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events (acute and late toxicity) as assessed by CTCAE v4.0 | The acute and late treatment-related toxicity are evaluated. | 2 year |
Not provided
Inclusion Criteria:
i. 19 years or older
ii. Patients who signed the informed consent form
iii. The clinical trial protocol can be complied with at the discretion of the investigator
iv. Performance status (based on ECOG) less than 2 (0, 1)
v. Patients with life expectancy greater than 3 months
vi. Condition in which primary cancer is controlled
• Definition: A condition that has not progressed at the time of review of clinical trials after curative treatment of primary cancer 3 months ago
vii. Number of metastatic lesions up to 5
viii. 3 or less metastatic lesions in one metastatic organ
ix. Those who are undergoing targeted therapy or chemotherapy can also be included (during radiation therapy, drug treatment is stopped)
Exclusion Criteria:
i. Serious medical complications that cannot proceed with radiation therapy
ii. Previous radiation therapy history at the location where radiation therapy is to be performed
iii. malignant pleural effusion
iv. When the spinal cord and the tumor are close (the tumor is located within 3 mm)
v. In case of brain metastasis requiring surgical intervention
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsil Seong | Contact | 82-2-2228-8111 | jsseong@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Jinsil Seong | Department of radiation oncology, Yonsei cancer center, Yonsei University College of Medicine, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38467379 | Derived | Choi SH, Lee BM, Kim J, Kim DY, Seong J. Efficacy of stereotactic ablative radiotherapy in patients with oligometastatic hepatocellular carcinoma: A phase II study. J Hepatol. 2024 Jul;81(1):84-92. doi: 10.1016/j.jhep.2024.03.003. Epub 2024 Mar 11. |
Not provided
Not provided
In case that individual participant data is being shared, the study protocol is planned to be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |