UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020596
Receipt number R000023097
Scientific Title Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Date of disclosure of the study information 2016/01/18
Last modified on 2020/07/21 14:07:38

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Basic information

Public title

Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies

Acronym

Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies

Scientific Title

Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies

Scientific Title:Acronym

Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies in a multicenter study

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

3-year overall survival rate

Key secondary outcomes

1) 3-year progression free survival rate
2) 3-year local control rate
3) incidence of adverse events
4) Incidence of radiation induced liver disease (RILD)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Proton beam therapy
A total dose of 66GyE (RBE=1.1) in 10 fractions (5 fractions/week)
For tumors within 2cm of the ports hepatic or gastrointestinal tract, a total dose of 72.6 GyE (RBE=1.1) in 22 fractions (5 fractions/week)

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) on dynamic CT or dynamic MRI within 28 days before registration
2) No prior treatment for HCC
3) Solitary HCC without extrahepatic lesions on chest and abdominal CT within 28 days before registration
4) Measurable tumor on dynamic CT or dynamic MRI within 28 days before registration and maximum tumor diameter <= 12 cm in the axial plane
5) Absence of invasion of the main trunk and/or major branches of the portal vein and the bile duct, or the inferior vena cava
6) No contact with the gastrointestinal tract
7) Unsuitable for resection or liver transplantation judged by a multidisciplinary meeting, prediction of severe deterioration in liver function after hepatic resection based on ICG R15, 99mTc-GSA scintigraphy, or CT volumetry
8) Unsuitable or difficult to undergo local ablative therapies judged by a multidisciplinary meeting
9) Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2 within 14 days before registration
10) Liver function of Child-Pugh class A within 14 days before registration
11) Absence of uncontrolled pleural effusion or ascites within 28 days before registration
12) Vital organ functions (listed below) are preserved within 14 days before registration
WBC count >= 1,500/mm3; hemoglobin level >= 7.0 g/dL; platelet count >= 30,000/mm3; total bilirubin <= 3.0 mg/dL; sGOT (AST) and sGPT (ALT) < 5.0 x upper limit of normal
13) Age 20-years old or over at the time of obtaining the consent form
14) Given written informed consent to this study

Key exclusion criteria

1) With other malignancies (simultaneous double cancer and heterochronic double cancer with disease-free time within 5 years), excluding lesions equivalent to carcinoma-in-situ or submucosal carcinoma
2) With esophageal or gastric varices at high risk for rupture within 28 days before registration
3) With active infection requiring systemic therapy
4) With a fever of 38 degrees Celsius or more
5) With cardiac infarction or unstable angina within 6 months before registration
6) With interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
7) Allergic to radiation
8) Considered that participation in this trial is difficult due to psychiatric symptoms or psychosis
9) Females who are pregnant, breast-feeding, within 28 days postpartum or have a possibility of conception
10) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Shirato

Organization

Hokkaido University Hospital

Division name

Department of Radiation Oncology

Zip code

060-8648

Address

North 14 West 5, Kita-Ku, Sapporo, Hokkaido

TEL

011-706-5977

Email

shirato@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Norio
Middle name
Last name Katoh

Organization

Hokkaido University Hospital

Division name

Department of Radiation Oncology

Zip code

060-8648

Address

North 14 West 5, Kita-Ku, Sapporo, Hokkaido

TEL

011-706-5977

Homepage URL


Email

noriwokatoh@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology, Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

AMED(Japan)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Clinical Research Review Board

Address

North 14 West 5, Kita-Ku, Sapporo, Hokkaido

Tel

011-706-7636

Email

crjimu@huhp.hokudai.ac.jp


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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 18 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

30

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

2016 Year 05 Month 12 Day

Date of IRB

2016 Year 06 Month 15 Day

Anticipated trial start date

2016 Year 06 Month 15 Day

Last follow-up date

2020 Year 04 Month 22 Day

Date of closure to data entry

2020 Year 05 Month 21 Day

Date trial data considered complete

2020 Year 06 Month 08 Day

Date analysis concluded

2020 Year 06 Month 26 Day


Other

Other related information



Management information

Registered date

2016 Year 01 Month 16 Day

Last modified on

2020 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023097


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name