UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020862
Receipt number R000024071
Scientific Title Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy
Date of disclosure of the study information 2016/02/03
Last modified on 2018/02/15 20:27:05

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Basic information

Public title

Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy

Acronym

Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy

Scientific Title

Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy

Scientific Title:Acronym

Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy

Region

Japan


Condition

Condition

Intrahepatic cholangiocarcinoma

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 intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy 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

2-year overall survival rate

Key secondary outcomes

1)2-year progression free survival rate
2)2-year local progression free survival rate
3)Adverse effect frequency
4)Radiation induced liver disease


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
22 times, once a day, 5 times a week, maximam 46 days, 30 cases

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Pathologically proven cholangiocarcinoma (adeno/adenosquamous carcinoma)
2)Inoperable
3)Nonresponsive to chemotherapy
4)Tumor diameter less than 12cm
5)Inclusive in the irradiation field
6)Child-pugh class A/B
7)PS 0-2
8)Both inpatients and outpatients
9)Laboratory data within 14 days before registration as follows:
-White blood cells>=2,000/mm3
- Platelet >=5*104/mm3
-Hemoglobine>=8,0 g/dL
-Total bilirubin<2,0 mg/dL
-Serum Albumin>3,5 g/dL
-Serum creatinine<=1,5 mg/dL
-Prothrombin time(%)>70%
10)Blood transfusion not received within 14 days before registration
11)Age>=20, <80
12)Informed consent obtained

Key exclusion criteria

1)Postoperative recurrence
2)Presence of lymph nodes metastases
3)Presence of distant metastases
4)Presence of active double cancers
5)Infection required systematic therapy
6)Body temperature more than 38 degree Celsius at screening
7)Pregnacy,demand of pregnant,28 days within childbirth and lactating
8)Psychosis or complicated mental symptom which causes difficult to entry
9)Steroid or other immunosuppressive drugs usage
10)Uncontrolled diabetes
11)Uncontrolled hypertension
12)Unstable angina within 3 weeks of myocardial infarction within 6 months
13)Presence of interstitial pneumonitis, pulmonary fibrosis, or severe emphysema which is diagnosed by chest CT
14)Esophageal varix (hemorrhagic,history of hemorrhage, more than F2,RC2)
15)Inappropriate decision by a principal investigator
16)Entry to other clinical research

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideyuki Sakurai

Organization

University of Tsukuba Hospital

Division name

Department of Radiation Oncology

Zip code


Address

2-1-1, Amakubo, Tsukuba, Ibarali, 305-8576

TEL

029-853-7100

Email

hsakurai@pmrc.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyuki Okumura

Organization

University of Tsukuba Hospital

Division name

Department of Radiation Oncology

Zip code


Address

2-1-1, Amakubo, Tsukuba, Ibarali, 305-8576

TEL

029-853-7100

Homepage URL


Email

okumura@pmrc.tsukuba.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology, University of Tsukuba Hospital

Institute

Department

Personal name



Funding Source

Organization

Japn Agency for Medical research and Development

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


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



Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 03 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

Preinitiation

Date of protocol fixation

2016 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 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

2016 Year 02 Month 03 Day

Last modified on

2018 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024071


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name