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Recruitment status Terminated
Unique ID issued by UMIN UMIN000016574
Receipt No. R000018980
Official scientific title of the study Real-time tumor-tracking proton beam therapy for liver cancer
Date of disclosure of the study information 2015/02/26
Last modified on 2017/08/21

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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/ctr_e/ctr_view.cgi?recptno=R000018980

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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