Proton Radiotherapy Versus Radiofrequency Ablation for Patients With Medium or Large Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT02640924|
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : March 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Radiation: Proton radiotherapy Procedure: Radiofrequency Ablation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2021|
Experimental: Proton radiotherapy
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.
Radiation: Proton radiotherapy
Experimental: Radiofrequency Ablation
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.
Procedure: Radiofrequency Ablation
- Local control rate (treatment in-field control rate) [ Time Frame: 3-year ]
- 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 ]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.
- Patient report outcome - fatigue as assessed by the functional assessment of cancer therapy (FACT-F) [ Time Frame: 3-year ]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.
- Patient report outcome - pain as assessed by the brief pain inventory-short form (BPI-SF) [ Time Frame: 3-year ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640924
|Contact: Bing-Shen Huang, MD||+886-3-3281200 ext firstname.lastname@example.org|
|Study Chair:||Shi-Ming Lin, MD||Chang Gung Memorial Hospital|