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Trial record 13 of 73 for:    liver proton

Proton Radiotherapy Versus Radiofrequency Ablation for Patients With Medium or Large Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Shi-Ming Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02640924
First received: December 7, 2015
Last updated: March 18, 2016
Last verified: March 2016
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
Radiation: Proton radiotherapy
Procedure: Radiofrequency Ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Local control rate (treatment in-field control rate) [ Time Frame: 3-year ]

Secondary Outcome Measures:
  • 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 ]
    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 - treatment satisfaction as assessed by the functional assessment of chronic illness therapy-treatment satisfaction-general (FACIT-TS-G) [ 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 - quality of life as assessed by the EQ-5D-3L [ 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.


Estimated Enrollment: 166
Study Start Date: January 2016
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02640924

Contacts
Contact: Bing-Shen Huang, MD +886-3-3281200 ext 7000 beanson.tw@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital, Linkou Recruiting
Taoyuan, Taiwan, 333
Contact: Bing-Shen Huang, MD    +886-3-328-1200 ext 7000    beanson.tw@gmail.com   
Contact: Cheng-En Hsieh, MD    +886-3-328-1200 ext 7000    rodney445@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Shi-Ming Lin, MD Chang Gung Memorial Hospital
  More Information

Publications:

Responsible Party: Shi-Ming Lin, Director of Liver Research Unit, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02640924     History of Changes
Other Study ID Numbers: 103-1278A3
Study First Received: December 7, 2015
Last Updated: March 18, 2016

Keywords provided by Chang Gung Memorial Hospital:
Hepatocellular carcinoma
Proton therapy
Radiation therapy
Switching control radiofrequency ablation

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases

ClinicalTrials.gov processed this record on March 28, 2017