UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016574
Receipt number R000018980
Scientific Title 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 14:34:35

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Basic information

Public title

Real-time tumor-tracking proton beam therapy for liver cancer

Acronym

Real-time tumor-tracking proton beam therapy for liver cancer

Scientific Title

Real-time tumor-tracking proton beam therapy for liver cancer

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroki Shirato

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Radiation Medicine

Zip code


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

1st name
Middle name
Last name Norio Katoh

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Radiation Medicine

Zip code


Address

North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan

TEL

+81-11-706-5977

Homepage URL


Email

noriwokatoh@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Radiation Medicine, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2015 Year 01 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018980


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name