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
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
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
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
