Carcinoma, HepatocellularPhase 3NCT02640924
Proton Radiotherapy Versus Radiofrequency Ablation for Patients With Medium or Large Hepatocellular Carcinoma
A Phase 3 study testing Proton radiotherapy and Radiofrequency Ablation in people with Carcinoma, Hepatocellular, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic viral hepatitis is common. Patients with HCC typically have impaired liver function because of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of them are appropriate candidates for surgery. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Proton radiotherapy and Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2021
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed hepatocellular carcinoma or lesion with typical triphasic CT or MRI imaging features for HCC
- Single tumor and tumor size > 3cm, ≦7cm in diameter
- Patients are unsuitable for resection or unwilling to accept surgery.
- Age ≥20 years old
- Eastern Cooperative Oncology Group performance status score of 0 or 1
- Child-Pugh score ≦ 8
- Willing to sign informed consent regarding participation in this study
Who cannot join
- Patients have received any treatment for HCC before this study
- Pregnancy/breast feeding women
- Tumor adjacent to bowel <1cm
- Extrahepatic metastasis
- Extrahepatic invasion
- Portal or hepatic vein tumor invasion/thrombosis
Show all 13Show fewer
- Uncontrolled ascites
- Glomerular filtration rate (GFR) < 30 ml/min*
- Platelet count < 50,000/L*
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years
- Ongoing medically significant active infection.
- MRI incompatible devices
- * Baseline laboratories results must be within the protocol range prior to sign informed consent. Repeat lab tests are permitted to evaluate eligibility during the Screening Period.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
Bing-Shen Huang, MD, +886-3-328-1200 ext. 7000, beanson.tw@gmail.com
Cheng-En Hsieh, MD, +886-3-328-1200 ext. 7000, rodney445@gmail.com
About this study
Official title: Proton Beam Radiotherapy Versus Switching Control Radiofrequency Ablation for Patients With Medium (>3, ≦5 cm) or Large (>5, ≦7cm) Treatment-naive Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic viral hepatitis is common. Patients with HCC typically have impaired liver function because of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of them are appropriate candidates for surgery. The 5-year overall survival for patients treated by surgery is approximately 30%-70%. For those not treated with surgery, liver function affected by an underlying liver disease has a strong influence on clinical outcomes, and complicates treatment strategies further than for other tumors. Maximal preservation of normal liver volume and function is an important consideration in the choice of treatment.
Proton beam has been applied to HCC treatment in Japan for longer than a decade, and several retrospective results showed excellent 3-5 years local control rate ranging from 85-95% and nearly no major complications. The investigators also retrospectively reviewed 75 index tumors sized 3.1-7.0cm in 70 patients receiving multiple-electrode radiofrequency ablation with switching controller (ME-SWC RFA) treatments in the period between 1 January 2009 and 31 December 2011 (Oral report in Taiwan Digestive Disease Week, October, 2012). Estimated 1-, 2-, and 3-year cumulative overall survival rates and local control rates were 94%, 85%, 81% and 89%, 83%, 67%, respectively.
Read more
Since ME-SWC RFA is the present one of standard modalities for non-surgery, moderate to larger (3-7 cm) HCC, and based on retrospective studies the local control rate of proton therapy was better than radiofrequency ablation, this prospective trial is aimed to compare the effects of these two modalities in 3-7 cm HCC patients who are not candidates for surgery or refuse surgery. This prospective study has high possibility to confirm the role of proton beam in HCC.
Along with the clinical trial, the investigators will also use next generation sequencing (NGS) to exam gene expression profile of tumor samples and find out candidate genes related to local control, intrahepatic control (treatment out-field control in liver), regional lymph node relapse, distant metastasis, and treatment response in HCC.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Proton radiotherapy, Radiofrequency Ablation
- Keywords
- Hepatocellular carcinoma, Proton therapy, Radiation therapy, Switching control radiofrequency ablation
- 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 radiotherapyRadiation
Radiofrequency AblationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Proton radiotherapy | Experimental | Proton radiotherapy will be totally 66 cobalt gray equivalent (CGE) in 10 fractions and delivered once daily, 5 fractions per week, over 2 weeks for HCC more than 1 cm away from the alimentary tract. Receives: Radiation: Proton radiotherapy |
| Radiofrequency Ablation | Experimental | Multiple-electrode radiofrequency with switch-controller system (ME-SWC RFA) can create a large coagulation necrosis volume and successful treat HCC sized more than 3 cm, extending to 8.5 cm. ME-SWC RFA system uses up to 3 electrodes parallel insertion to inside of the tumors with an equilateral triangular confirmation before initiation of ablation. The distances between electrodes are about 1.5-2 cm, estimated by ultrasound measuring. The switching machine is set on the auto-mode, and all electrodes work alternately and switching each other automatically after impendence surge. Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate (treatment in-field control rate)
Measured: 3-year
Secondary outcomes (14)
Overall survival rate
Measured: 3-year
Intrahepatic control rate
Measured: 3-year
Distant metastasis free survival rate
Measured: 3-year
Local control rate (treatment in-field control rate)
Measured: 5-year
Overall survival rate
Measured: 5-year
Intrahepatic control rate
Measured: 5-year
Distant metastasis free survival rate
Measured: 5-year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3-year
Patient report outcome - quality of life as assessed by the functional assessment of cancer therapy - hepatobiliary (FACT-Hep)
The data will be collected 17 times from enrollment to the 36th month after treatment. Specific measurement points are: baseline, day 3, day 7, day 14, month 1, month 3, then every 3 months to the 36th month after treatment.
Measured: 3-year
Patient report outcome - fatigue as assessed by the functional assessment of cancer therapy (FACT-F)
The data will be collected 17 times from enrollment to the 36th month after treatment. Specific measurement points are: baseline, day 3, day 7, day 14, month 1, month 3, then every 3 months to the 36th month after treatment.
Measured: 3-year
Patient report outcome - pain as assessed by the brief pain inventory-short form (BPI-SF)
The data will be collected 17 times from enrollment to the 36th month after treatment. Specific measurement points are: baseline, day 3, day 7, day 14, month 1, month 3, then every 3 months to the 36th month after treatment.
Measured: 3-year
Patient report outcome - symptom distress as assessed by the Memorial symptom assessment scale-short form (MSAS-SF)
The data will be collected 17 times from enrollment to the 36th month after treatment. Specific measurement points are: baseline, day 3, day 7, day 14, month 1, month 3, then every 3 months to the 36th month after treatment.
Measured: 3-year
Patient report outcome - treatment satisfaction as assessed by the functional assessment of chronic illness therapy-treatment satisfaction-general (FACIT-TS-G)
The data will be collected 17 times from enrollment to the 36th month after treatment. Specific measurement points are: baseline, day 3, day 7, day 14, month 1, month 3, then every 3 months to the 36th month after treatment.
Measured: 3-year
Patient report outcome - quality of life as assessed by the EQ-5D-3L
The data will be collected 17 times from enrollment to the 36th month after treatment. Specific measurement points are: baseline, day 3, day 7, day 14, month 1, month 3, then every 3 months to the 36th month after treatment.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Ming Lin, Chang Gung Memorial Hospital
- Investigators
- Shi-Ming Lin, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640924
- Sponsor's protocol ID
- 103-1278A3
- Status last verified
- Mar 2016
- First submitted
- 7 Dec 2015
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kan Z, Zheng H, Liu X, Li S, Barber TD, Gong Z, Gao H, Hao K, Willard MD, Xu J, Hauptschein R, Rejto PA, Fernandez J, Wang G, Zhang Q, Wang B, Chen R, Wang J, Lee NP, Zhou W, Lin Z, Peng Z, Yi K, Chen S, Li L, Fan X, Yang J, Ye R, Ju J, Wang K, Estrella H, Deng S, Wei P, Qiu M, Wulur IH, Liu J, Ehsani ME, Zhang C, Loboda A, Sung WK, Aggarwal A, Poon RT, Fan ST, Wang J, Hardwick J, Reinhard C, Dai H, Li Y, Luk JM, Mao M. Whole-genome sequencing identifies recurrent mutations in hepatocellular carcinoma. Genome Res. 2013 Sep;23(9):1422-33. doi: 10.1101/gr.154492.113. Epub 2013 Jun 20.
PubMed 23788652Mizumoto M, Okumura T, Hashimoto T, Fukuda K, Oshiro Y, Fukumitsu N, Abei M, Kawaguchi A, Hayashi Y, Ookawa A, Hashii H, Kanemoto A, Moritake T, Tohno E, Tsuboi K, Sakae T, Sakurai H. Proton beam therapy for hepatocellular carcinoma: a comparison of three treatment protocols. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1039-45. doi: 10.1016/j.ijrobp.2010.07.015. Epub 2010 Oct 1.
PubMed 20888707Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.
PubMed 18483229Lee J, Lee JM, Yoon JH, Lee JY, Kim SH, Lee JE, Han JK, Choi BI. Percutaneous radiofrequency ablation with multiple electrodes for medium-sized hepatocellular carcinomas. Korean J Radiol. 2012 Jan-Feb;13(1):34-43. doi: 10.3348/kjr.2012.13.1.34. Epub 2011 Dec 23.
PubMed 22247634Lee JM, Han JK, Kim HC, Kim SH, Kim KW, Joo SM, Choi BI. Multiple-electrode radiofrequency ablation of in vivo porcine liver: comparative studies of consecutive monopolar, switching monopolar versus multipolar modes. Invest Radiol. 2007 Oct;42(10):676-83. doi: 10.1097/RLI.0b013e3180661aad.
PubMed 17984764
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Beam Radiotherapy Versus Switching Control Radiofrequency Ablation for Patients With Medium (>3, ≦5 cm) or Large (>5, ≦7cm) Treatment-naive Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02640924
- Acronym / sponsor ID
- 103-1278A3
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular carcinoma, Proton therapy, Radiation therapy, Switching control radiofrequency ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 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.
Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic viral hepatitis is common. Patients with HCC typically have impaired liver function because of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of them are appropriate candidates for surgery. The 5-year overall survival for patients treated by surgery is approximately 30%-70%. For those not treated with surgery, liver function affected by an underlying liver disease has a strong influence on clinical outcomes, and complicates treatment strategies further than for other tumors. Maximal preservation of normal liver volume and function is an important consideration in the choice of treatment.
Proton beam has been applied to HCC treatment in Japan for longer than a decade, and several retrospective results showed excellent 3-5 years local control rate ranging from 85-95% and nearly no major complications. The investigators also retrospectively reviewed 75 index tumors sized 3.1-7.0cm in 70 patients receiving multiple-electrode radiofrequency ablation with switching controller (ME-SWC RFA) treatments in the period between 1 January 2009 and 31 December 2011 (Oral report in Taiwan Digestive Disease Week, October, 2012). Estimated 1-, 2-, and 3-year cumulative overall survival rates and local control rates were 94%, 85%, 81% and 89%, 83%, 67%, respectively.
Since ME-SWC RFA is the present one of standard modalities for non-surgery, moderate to larger (3-7 cm) HCC, and based on retrospective studies the local control rate of proton therapy was better than radiofrequency ablation, this prospective trial is aimed to compare the effects of these two modalities in 3-7 cm HCC patients who are not candidates for surgery or refuse surgery. This prospective study has high possibility to confirm the role of proton beam in HCC.
Along with the clinical trial, the investigators will also use next generation sequencing (NGS) to exam gene expression profile of tumor samples and find out candidate genes related to local control, intrahepatic control (treatment out-field control in liver), regional lymph node relapse, distant metastasis, and treatment response in HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton radiotherapy | Experimental | Radiation: Proton radiotherapyProton radiotherapy will be totally 66 cobalt gray equivalent (CGE) in 10 fractions and delivered once daily, 5 fractions per week, over 2 weeks for HCC more than 1 cm away from the alimentary tract. |
| Radiofrequency Ablation | Experimental | Procedure: Radiofrequency AblationMultiple-electrode radiofrequency with switch-controller system (ME-SWC RFA) can create a large coagulation necrosis volume and successful treat HCC sized more than 3 cm, extending to 8.5 cm. ME-SWC RFA system uses up to 3 electrodes parallel insertion to inside of the tumors with an equilateral triangular confirmation before initiation of ablation. The distances between electrodes are about 1.5-2 cm, estimated by ultrasound measuring. The switching machine is set on the auto-mode, and all electrodes work alternately and switching each other automatically after impendence surge. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed hepatocellular carcinoma or lesion with typical triphasic CT or MRI imaging features for HCC
- Single tumor and tumor size > 3cm, ≦7cm in diameter
- Patients are unsuitable for resection or unwilling to accept surgery.
- Age ≥20 years old
- Eastern Cooperative Oncology Group performance status score of 0 or 1
Key exclusion criteria (13 listed)
- Patients have received any treatment for HCC before this study
- Pregnancy/breast feeding women
- Tumor adjacent to bowel <1cm
- Extrahepatic metastasis
- Extrahepatic invasion
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 radiotherapy | Radiation | Proton radiotherapy |
| Radiofrequency Ablation | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Local control rate (treatment in-field control rate)
Time frame: 3-year
14 secondary outcomes
Overall survival rate
Time frame: 3-year
Intrahepatic control rate
Time frame: 3-year
Distant metastasis free survival rate
Time frame: 3-year
Local control rate (treatment in-field control rate)
Time frame: 5-year
Overall survival rate
Time frame: 5-year
Intrahepatic control rate
Time frame: 5-year
Distant metastasis free survival rate
Time frame: 5-year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3-year
Patient report outcome - quality of life as assessed by the functional assessment of cancer therapy - hepatobiliary (FACT-Hep)
Time frame: 3-year
Patient report outcome - fatigue as assessed by the functional assessment of cancer therapy (FACT-F)
Time frame: 3-year
Patient report outcome - pain as assessed by the brief pain inventory-short form (BPI-SF)
Time frame: 3-year
Patient report outcome - symptom distress as assessed by the Memorial symptom assessment scale-short form (MSAS-SF)
Time frame: 3-year
Patient report outcome - treatment satisfaction as assessed by the functional assessment of chronic illness therapy-treatment satisfaction-general (FACIT-TS-G)
Time frame: 3-year
Patient report outcome - quality of life as assessed by the EQ-5D-3L
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Background: PubMed 23788652Kan Z, Zheng H, Liu X, Li S, Barber TD, Gong Z, Gao H, Hao K, Willard MD, Xu J, Hauptschein R, Rejto PA, Fernandez J, Wang G, Zhang Q, Wang B, Chen R, Wang J, Lee NP, Zhou W, Lin Z, Peng Z, Yi K, Chen S, Li L, Fan X, Yang J, Ye R, Ju J, Wang K, Estrella H, Deng S, Wei P, Qiu M, Wulur IH, Liu J, Ehsani ME, Zhang C, Loboda A, Sung WK, Aggarwal A, Poon RT, Fan ST, Wang J, Hardwick J, Reinhard C, Dai H, Li Y, Luk JM, Mao M. Whole-genome sequencing identifies recurrent mutations in hepatocellular carcinoma. Genome Res. 2013 Sep;23(9):1422-33. doi: 10.1101/gr.154492.113. Epub 2013 Jun 20.
- Results publication: PubMed 20888707Mizumoto M, Okumura T, Hashimoto T, Fukuda K, Oshiro Y, Fukumitsu N, Abei M, Kawaguchi A, Hayashi Y, Ookawa A, Hashii H, Kanemoto A, Moritake T, Tohno E, Tsuboi K, Sakae T, Sakurai H. Proton beam therapy for hepatocellular carcinoma: a comparison of three treatment protocols. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1039-45. doi: 10.1016/j.ijrobp.2010.07.015. Epub 2010 Oct 1.
- Results publication: PubMed 18483229Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.
- Results publication: PubMed 22247634Lee J, Lee JM, Yoon JH, Lee JY, Kim SH, Lee JE, Han JK, Choi BI. Percutaneous radiofrequency ablation with multiple electrodes for medium-sized hepatocellular carcinomas. Korean J Radiol. 2012 Jan-Feb;13(1):34-43. doi: 10.3348/kjr.2012.13.1.34. Epub 2011 Dec 23.
- Results publication: PubMed 17984764Lee JM, Han JK, Kim HC, Kim SH, Kim KW, Joo SM, Choi BI. Multiple-electrode radiofrequency ablation of in vivo porcine liver: comparative studies of consecutive monopolar, switching monopolar versus multipolar modes. Invest Radiol. 2007 Oct;42(10):676-83. doi: 10.1097/RLI.0b013e3180661aad.
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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.
Shi-Ming Lin, MD study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Proton radiotherapy and Radiofrequency Ablation in people with Carcinoma, Hepatocellular, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 inclusion and 13 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 21 Mar 2016. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Bing-Shen Huang, MD (+886-3-3281200 ext. 7000, beanson.tw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate (treatment in-field control rate) (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02640924, which also lists 5 linked publications.
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 21 Mar 2016.