Liver NeoplasmPhase 2NCT02632864
Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial
A Phase 2 study testing Proton arm in people with Liver Neoplasm and Proton Therapy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit in several randomized phase III trials, the benefit was modest. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Neoplasm, Proton Therapy
- What is being tested?
- Proton arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma (HCC) patients (Pathologically proven or HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline)
- Not indicated with surgical resection and/or RFA
- Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
- Eastern Cooperative Oncology Group performance status 0 to 2 within 1 week before participate
- Adequate bone marrow function (absolute neutrophil count ≥ 1.0 x 109/l, platelet ≥ 30 x 109/l, hemoglobin ≥ 8 g/dl)
- Adequate liver/renal function within 1 week before participate
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- Total bilirubin <3.0 mg/dL, Prothrombin time/International normalized ratio <1.7, Albumin≥2.8g/dL, Aspartate aminotransferase/alanine aminotransferase<6 times of upper normal limit Serum creatinine < 1.5 x upper normal limit, glomerular filtration rate > 50 ml/min
- Informed consent
- If viable tumor is single, 1 cm to 10 cm
- Less than 3 nodules
- Child-Pugh class A, B, or early C (score ≤ 10)
- Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of RT
Who cannot join
- Uncontrolled hepatic encephalopathy
- Previous history of upper abdominal radiotherapy
- Status of pregnancy or breast feeding
- Less than 12 weeks of expected survival
- Uncontrolled ascites
- Combined with disease known as radiosensitive disorder (connective tissue disorder, Ataxia-telangiectasia)
- Hard to maintain stable respiration less than 5 minutes related with respiratory disease
- Combined with uncontrolled severe acute disease other than liver
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Joon Hyeok Lee, MD, PhD, 82-2-3410-3409, gijhlee.lee@samsung.com
Hee Chul Park, MD, PhD, 82-2-3410-2612, hee.ro.park@samsung.com
About this study
The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit in several randomized phase III trials, the benefit was modest.
Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT techniques, showed favorable response rate with acceptable local control rate. Based on those promising results, RT was actively applied in HCC who are not indicated with surgery and/or radiofrequency ablation.
Read more
Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose.
Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively.
In this background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients who are not indicated with surgery and/or radiofrequency ablation (RFA).
- Conditions
- Liver Neoplasm, Proton Therapy
- Being tested
- Proton arm
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton armRadiation
Proton beam therapy
| Study group | Role | What they receive |
|---|---|---|
| Proton arm | Experimental | Proton beam therapy Receives: Radiation: Proton arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
two-year overall survival
Measured: two-year after proton beam therapy
Secondary outcomes (15)
1 month objective response rate
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Measured: 1 month after proton beam therapy
3 month objective response rate
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Measured: 3 months after proton beam therapy
6 month objective response rate
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Measured: 6 months after proton beam therapy
1 year progression free survival
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Measured: one-year after proton beam therapy
1 year local progression free survival
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Measured: one-year after proton beam therapy
6 months adverse event
Common Terminology Criteria for Adverse Event v4.0 (CTCAE v4.0) will be used.
Measured: 6 months after proton beam therapy
1 year adverse event
Common Terminology Criteria for Adverse Event v4.0 (CTCAE v4.0) will be used.
Measured: 1 year after proton beam therapy
Baseline Quality of life assessment by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ C-30)
Measured: Within 2 week before proton beam therapy started
1 month Quality of life assessment by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ C-30) compared with baseline
Measured: 1 month after proton beam therapy
3 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
Measured: 3 month after proton beam therapy
6 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
Measured: 6 month after proton beam therapy
Baseline Indocyanine green (ICG)
ICG Retention rate at 15 minute will be used.
Measured: Within 2 week before proton beam therapy started
Indocyanine green (ICG) test change compared with baseline
ICG Retention rate at 15 minute will be used.
Measured: 3 month after proton beam therapy
Baseline hepatobiliary phase signal
Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.
Measured: Within 2 week before proton beam therapy started
Hepatobiliary phase signal change after proton beam therapy
Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.
Measured: 3 month after proton beam therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2019 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon-Hyeok Lee, Samsung Medical Center
- Investigators
- Joon Hyeok Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632864
- Sponsor's protocol ID
- 2015-08-004
- Status last verified
- Apr 2018
- First submitted
- 7 Dec 2015
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT02632864
- Acronym / sponsor ID
- 2015-08-004
- Conditions
- Liver Neoplasm, Proton Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit in several randomized phase III trials, the benefit was modest.
Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT techniques, showed favorable response rate with acceptable local control rate. Based on those promising results, RT was actively applied in HCC who are not indicated with surgery and/or radiofrequency ablation.
Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose.
Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively.
In this background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients who are not indicated with surgery and/or radiofrequency ablation (RFA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton arm | Experimental | Radiation: Proton armProton beam therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Hepatocellular carcinoma (HCC) patients (Pathologically proven or HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline)
- Not indicated with surgical resection and/or RFA
- Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
- Eastern Cooperative Oncology Group performance status 0 to 2 within 1 week before participate
- Adequate bone marrow function (absolute neutrophil count ≥ 1.0 x 109/l, platelet ≥ 30 x 109/l, hemoglobin ≥ 8 g/dl)
Key exclusion criteria (8 listed)
- Uncontrolled hepatic encephalopathy
- Previous history of upper abdominal radiotherapy
- Status of pregnancy or breast feeding
- Less than 12 weeks of expected survival
- Uncontrolled ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton armProton beam therapy | Radiation | Proton arm |
Primary outcome
two-year overall survival
Time frame: two-year after proton beam therapy
15 secondary outcomes
1 month objective response rate
Time frame: 1 month after proton beam therapy
3 month objective response rate
Time frame: 3 months after proton beam therapy
6 month objective response rate
Time frame: 6 months after proton beam therapy
1 year progression free survival
Time frame: one-year after proton beam therapy
1 year local progression free survival
Time frame: one-year after proton beam therapy
6 months adverse event
Time frame: 6 months after proton beam therapy
1 year adverse event
Time frame: 1 year after proton beam therapy
Baseline Quality of life assessment by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ C-30)
Time frame: Within 2 week before proton beam therapy started
1 month Quality of life assessment by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ C-30) compared with baseline
Time frame: 1 month after proton beam therapy
3 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
Time frame: 3 month after proton beam therapy
6 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
Time frame: 6 month after proton beam therapy
Baseline Indocyanine green (ICG)
Time frame: Within 2 week before proton beam therapy started
Indocyanine green (ICG) test change compared with baseline
Time frame: 3 month after proton beam therapy
Baseline hepatobiliary phase signal
Time frame: Within 2 week before proton beam therapy started
Hepatobiliary phase signal change after proton beam therapy
Time frame: 3 month after proton beam therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon Hyeok Lee, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proton arm in people with Liver Neoplasm and Proton Therapy, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon Hyeok Lee, MD, PhD (82-2-3410-3409, gijhlee.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
two-year overall survival (time frame: two-year after proton beam therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.