Hepatocellular CarcinomaNCT02395523
Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma
A study testing Proton Beam Therapy in people with Hepatocellular Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Proton Beam Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2015to 18 May 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular Carcinoma diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
- Inoperable HCC or refusal to surgery
- Recurrent/residual tumor after other local treatments (local ablation therapy, or transarterial chemoemobolization, etc), or unsuitable/refusal to other treatments.
- Patients without evidence of extrahepatic metastasis
- The largest diameter of tumor should be less than 7cm, and the number of tumor ≤2
- The targeted tumors is more than 2cm away from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel)
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- No previous treatment to target tumors by other forms of RT
- Liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
- Age of ≥18 years
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) score
- Required Entry Laboratory Parameters WBC count ≥ 1,500/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 30,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no uncontrolled ascites
- No serious comorbidities other than liver cirrhosis
- Signed informed consent form prior to study entry
Who cannot join
- There is evidence of extrahepatic metastasis.
- Age of <18 years
- Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of >7)
- Previous history of other forms of RT adjacent to target tumors
- Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
- Multicentric HCCs, except for those with the following two conditions: (i) multinodular aggregating HCC that could be encompassed by single clinical target volume and within single clinical target volume; (ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
- Pregnant or breast feeding status
- Previous history uncontrolled other malignancies within 2 years
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 411-769
About this study
Official title: A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.
Read the detailed description
The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients will be enrolled.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Proton Beam Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam TherapyRadiation
Also called Radiotherapy
Definition of target volume:
- Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan
- Clinical target volume (CTV) = GTV + internal target volume
- Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins.
Radiation dose and planning
- Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week
- Dose prescription : 95% isodose volume of prescribed dose encompassed PTV
| Study group | Role | What they receive |
|---|---|---|
| Proton Beam Therapy | Experimental | Definition of target volume:
* Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan
* Clinical target volume (CTV) = GTV + internal target volume
* Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins.
Radiation dose and planning
* Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week
* Dose prescription : 95% isodose volume of prescribed dose encompassed PTV Receives: Radiation: Proton Beam Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local progression - free survival
During PBT, patients were assessed weekly and after comletion of PBT at the 1st month, every 3months for the first 2years, every 6 months up to 5years. the tumor responses were assessed according to the modified response evaluation criteria in solid tumors criteria by comparing pre- and posst-PBT CT/MRI scans, and the severity of adverse deffects was graded using the common terminology criteria for adverse events(ver 4.0)
Measured: Up to 5 year
Secondary outcomes (1)
overall survival
During PBT, patients were assessed weekly and after com;letion of PBT at the 1st month, every 3months for the first 2years, every 6 months up to 5years. the tumor responses were assessed according to the modified response evaluation criteria in solid tumors criteria by comparing pre- and posst-PBT CT/MRI scans, and the severity of adverse deffects was graded using the common terminology criteria for adverse events(ver 4.0)
Measured: Up to5 years until study closed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study start5 Mar 2015
- Primary completion26 Mar 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tae Hyun Kim, National Cancer Center, Korea
- Investigators
- Tae Hyun Kim, Ph.D, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395523
- Sponsor's protocol ID
- NCCCTS-15-042
- Status last verified
- Jul 2020
- First submitted
- 17 Mar 2015
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02395523
- Acronym / sponsor ID
- NCCCTS-15-042
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 23 Mar 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.
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.
Detailed description
The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Beam Therapy | Experimental | Radiation: Proton Beam TherapyDefinition of target volume: * Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan * Clinical target volume (CTV) = GTV + internal target volume * Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins. Radiation dose and planning * Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week * Dose prescription : 95% isodose volume of prescribed dose encompassed PTV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hepatocellular Carcinoma diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
- Inoperable HCC or refusal to surgery
- Recurrent/residual tumor after other local treatments (local ablation therapy, or transarterial chemoemobolization, etc), or unsuitable/refusal to other treatments.
- Patients without evidence of extrahepatic metastasis
- The largest diameter of tumor should be less than 7cm, and the number of tumor ≤2
Key exclusion criteria (8 listed)
- There is evidence of extrahepatic metastasis.
- Age of <18 years
- Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of >7)
- Previous history of other forms of RT adjacent to target tumors
- Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
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 Beam TherapyAlso: RadiotherapyDefinition of target volume: * Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan * Clinical target volume (CTV) = GTV + internal target volume * Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins. Radiation dose and planning * Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week * Dose prescription : 95% isodose volume of prescribed dose encompassed PTV | Radiation | Proton Beam Therapy |
Primary outcome
local progression - free survival
Time frame: Up to 5 year
During PBT, patients were assessed weekly and after comletion of PBT at the 1st month, every 3months for the first 2years, every 6 months up to 5years. the tumor responses were assessed according to the modified response evaluation criteria in solid tumors criteria by comparing pre- and posst-PBT CT/MRI scans, and the severity of adverse deffects was graded using the common terminology criteria for adverse events(ver 4.0)
1 secondary outcome
overall survival
Time frame: Up to5 years until study closed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
Tae Hyun Kim, Ph.D principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Beam Therapy in people with Hepatocellular Carcinoma, run by National Cancer Center, Korea 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 13 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: finished, as of the sponsor's last update on 7 Jul 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local progression - free survival (time frame: Up to 5 year). 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 7 Jul 2020.