UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Real-time tumor-tracking proton beam therapy for liver cancer
Title of the study (Brief title)	Real-time tumor-tracking proton beam therapy for liver cancer
Region	Japan

Condition
Condition	Primary liver cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety and efficacy of real-time tumor-tracking proton beam therapy for hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Incidence of proton-induced hepatic insufficiency within 6 months after real-time tumor-tracking proton beam therapy. Development of hepatic insufficiency presented with anicteric ascites and/or asterixis within 6 months after completion of proton beam therapy in the absence of disease progression was defined as proton-induced hepatic insufficiency.
Key secondary outcomes	2-year overall survival, local control, progression free survival, recurrence pattern, incidence of adverse effect, incidence of dropout of internal fiducial markers during treatment period

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Real-time tumor-tracking proton beam therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pathologically proven or Radiologically diagnosed hepatocellular carcinoma (HCC) 2) WBC count >= 2,000/mm3; hemoglobin level >= 7.5 g/dL; platelet count >= 25,000/mm3; total bilirubin <= 3.0 mg/dL; SGOT (AST) and SGPT (ALT) < 5.0 x upper limit of normal 3) Unfeasible, difficult or refusal to undergo surgery or radiofrequency ablation 4) Visible target on CT and/or MRI 5) ECOG-PS 0-2 6) Age 20-yrs old or over at the time of consent form is obtained 7) Explained well and consent to this study
Key exclusion criteria	1) With active infections in the irradiated sites 2) With active other cancers 3) With severe uncontrolled diabetes 4) With severe renal failure which needed dialysis 5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 6) With an inflammatory bowel syndrome, i.e., Crohn's disease, ulcerative colitis 7) Previous abdominal irradiation 8) Previous treatment for the tumor within 30 days 9) With ascites of grade 2 or higher (CTCAE ver4.03) 10) Hepatic function characterized by a Child-Pugh score 10 or over 11) Extrahepatic metastasis 12) Multicentric HCCs, except for those with the following two conditions: (1) multinodular aggregating HCC that could be encompassed by single clinical target volume; (2) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy. 13) Maximum tumor diameter on CT and/or MRI over 10 cm 14) Tumor within 2 cm of the gastrointestinal tract 15) Total occlusion of the main trunk and/or major branches of the portal vein (the main left and right portal veins) by tumor thrombus. 16) With implantable cardioverter defibrillator or permanent pacemaker 17) Pregnancy 18) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 19) Cannot be held rest for about 30 minutes 20) Weight over 135 kg 21) Cannot be implanted Au marker in the lung 22) Allergic to radiation 23) Unsuitable for enrollment judged by principal investigator
Target sample size	24

Research contact person
Name of lead principal investigator	Hiroki Shirato
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Radiation Medicine
Address	North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL	+81-11-706-5977
Email	shirato@med.hokudai.ac.jp

Public contact
Name of contact person	Norio Katoh
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Radiation Medicine
Address	North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL	+81-11-706-5977
Homepage URL
Email	noriwokatoh@med.hokudai.ac.jp

Sponsor
Institute	Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 14 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 18 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018980