Carcinoma, HepatocellularPhase 1NCT00662246
Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma
A Phase 1 study testing respiratory gated proton beam radiotherapy in people with Carcinoma, Hepatocellular, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for 10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For an inoperable case, we can consider Liver transplantation. But there is not enough organ donor and it is very expensive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- respiratory gated proton beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Mar 2010
- Phase
- Phase 1
- 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
- HCC 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 400 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms
- (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 400 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
- HCC patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
- Without evidence of extrahepatic metastasis
- All target tumors must be encompassable within single irradiation field (12x12 cm maximum)
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- No previous treatment to target tumors by other forms of RT
- Digestive tract not in contact with clinical target volume
- Liver function of Child-Pugh class A or B
- Age of ≥ 18 years
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
- WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 25,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no ascites)
- No serious comorbidities other than liver cirrhosis
Who cannot join
- Evidence of extrahepatic metastasis
- Age < 18 years
- Liver function of Child-Pugh class C
- Previous history of other forms of RT adjacent to target tumors
- Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
- Diffusely infiltrating tumor which is difficult to define the gross tumor volume accurately
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- 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 irradiation field (15x15 cm maximum)
- (ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy
- Digestive tract in contact with clinical target volume
- 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, 410-769
About this study
Official title: A Phase I Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma
The radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for 10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For an inoperable case, we can consider Liver transplantation. But there is not enough organ donor and it is very expensive. In that case, various treatment modalities for HCC (i.e., transcatheter arterial embolization [TAE] and percutaneous ethanol injection [PEI], radiofrequency ablation etc.) have become clinically available. In addition, after these treatment, radiation therapy can be conducted as a combined treatment. If it is difficult, radiation therapy can be conducted alone. In this case, radiation therapy can use fractionated stereotactic radiation therapy [FSRT] or 3D simulation to minimize the exposure to normal tissues. In recent years, Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation. The purpose of this trial is to improve the therapeutic effects by using proton therapy.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- respiratory gated proton beam radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory gated proton beam radiotherapyRadiation
- Prescription dose to PTV as according to the following dose escalation schema: Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Primary objectives :
* to determine the recommended dose (i.e., the safest and most effective dose) by evaluating frequency of patients developing unacceptable (grade 3 or higher) acute toxicities attributable to proton beam radiotherapy for HCC. Receives: Radiation: respiratory gated proton beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662246
- Sponsor's protocol ID
- NCCCTS-07-225
- Status last verified
- Mar 2012
- First submitted
- 10 Apr 2008
- Last updated
- 3 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00662246
- Acronym / sponsor ID
- NCCCTS-07-225
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Apr 2008 (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 radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for 10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For an inoperable case, we can consider Liver transplantation. But there is not enough organ donor and it is very expensive. In that case, various treatment modalities for HCC (i.e., transcatheter arterial embolization [TAE] and percutaneous ethanol injection [PEI], radiofrequency ablation etc.) have become clinically available. In addition, after these treatment, radiation therapy can be conducted as a combined treatment. If it is difficult, radiation therapy can be conducted alone. In this case, radiation therapy can use fractionated stereotactic radiation therapy [FSRT] or 3D simulation to minimize the exposure to normal tissues. In recent years, Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation. The purpose of this trial is to improve the therapeutic effects by using proton therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: respiratory gated proton beam radiotherapyPrimary objectives : * to determine the recommended dose (i.e., the safest and most effective dose) by evaluating frequency of patients developing unacceptable (grade 3 or higher) acute toxicities attributable to proton beam radiotherapy for HCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- HCC diagnosed as:
- HCC patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
- Without evidence of extrahepatic metastasis
- All target tumors must be encompassable within single irradiation field (12x12 cm maximum)
- No previous treatment to target tumors by other forms of RT
Key exclusion criteria (12 listed)
- Evidence of extrahepatic metastasis
- Age < 18 years
- Liver function of Child-Pugh class C
- Previous history of other forms of RT adjacent to target tumors
- Poor performance status of 3 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 |
|---|---|---|
| respiratory gated proton beam radiotherapy- Prescription dose to PTV as according to the following dose escalation schema: Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week. | Radiation | 1 |
Primary outcome
all cause mortality
Time frame: 2 years
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 3 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing respiratory gated proton beam radiotherapy in people with Carcinoma, Hepatocellular, 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 12 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 3 Apr 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
all cause mortality (time frame: 2 years). 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 3 Apr 2012.