Oligometastasis Hepatocellular CarcinomaPhase 2NCT05173610
Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma
A Phase 2 study testing Radiation: Stereotactic body radiotherapy (SBRT) in people with Oligometastasis Hepatocellular Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Oligometastasis Hepatocellular Carcinoma
- What is being tested?
- Radiation: Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2021to 27 Sep 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years or older
- Patients who signed the informed consent form
- The clinical trial protocol can be complied with at the discretion of the investigator
- Performance status (based on ECOG) less than 2 (0, 1)
- Patients with life expectancy greater than 3 months
- Condition in which primary cancer is controlled
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- Definition: A condition that has not progressed at the time of review of clinical trials after curative treatment of primary cancer 3 months ago
- Number of metastatic lesions up to 5
- 3 or less metastatic lesions in one metastatic organ
- Those who are undergoing targeted therapy or chemotherapy can also be included (during radiation therapy, drug treatment is stopped)
Who cannot join
- Serious medical complications that cannot proceed with radiation therapy
- Previous radiation therapy history at the location where radiation therapy is to be performed
- malignant pleural effusion
- When the spinal cord and the tumor are close (the tumor is located within 3 mm)
- In case of brain metastasis requiring surgical intervention
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Jinsil Seong, 82-2-2228-8111, jsseong@yuhs.ac
About this study
Official title: Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma: Phase II Trial
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
- Being tested
- Radiation: Stereotactic body radiotherapy (SBRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: Stereotactic body radiotherapy (SBRT)Radiation
Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma.
- 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.
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| SBRT arm | Experimental | Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma Receives: Radiation: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 year
Secondary outcomes (1)
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start28 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion27 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oligometastasis Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinsil Seong, Principal investigator, Department of radiation oncology, Yonsei cancer center, Yonsei University College of Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173610
- Sponsor's protocol ID
- 4-2021-1101
- Status last verified
- Aug 2022
- First submitted
- 23 Nov 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In case that individual participant data is being shared, the study protocol is planned to be shared.
Publications
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.
PubMed 38467379