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Recruitment status Completed
Unique ID issued by UMIN UMIN000020436
Receipt No. R000023505
Official scientific title of the study Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)
Date of disclosure of the study information 2016/01/05
Last modified on 2016/01/05

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Basic information
Official scientific title of the study Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)
Title of the study (Brief title) Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)
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 evaluate the safety of carbon-ion radiotherapy using 12 fractions for liver cancer adjacent to the alimentary tract.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dose-limiting toxicity
Acute toxicity
Key secondary outcomes Response rate
Late toxicity

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Maneuver
Interventions/Control_1 Carbon-ion radiation therapy
Total dose 60.0-64.8 Gy(RBE)
12 fractions
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) pathollogically or clinically diagnosed primary liver tumor (hepatocellular carcinoma or cholangiocellular carcinoma).
2) The distance between taget lesion and digestive tract is 1 cm or less than 1 cm.
3) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor.
4) Tumor is measurable and tumor size is 10 cm or less than 10 cm.
5) Absence of invasion to the main portal vein, common hepatic duct, or inferior vena cava.
6) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
7) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE.
8) Child-Pugh score of the patient is from 5 points to 9 points.
9) Perfomance status of the patient is from 0 to 2.
8) Child-Pugh score of the patient is from 5 points to 9 points.
9) Expected survival over 6 months.
10) Perfomance status of the patient is from 0 to 2.
11) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria 1) History of radiation therapy to the lesion of interest.
2) Invasion to the adjacent organs.
3) Patient with severe comorbidity.
Target sample size 6

Research contact person
Name of lead principal investigator Takashi Nakano
Organization Gunma University
Division name Heavy Ion Medical Center
Address 3-39-22 Showa, Maebashi, Gunma
TEL 027-220-8378
Email tnakano@gunma-u.ac.jp

Public contact
Name of contact person Tatsuya Ohno
Organization Gunma University
Division name Heavy Ion Medical Center
Address 3-39-22 Showa, Maebashi, Gunma
TEL 027-220-8378
Homepage URL
Email tohno@gunma-u.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 05 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 06 Month 06 Day
Anticipated trial start date
2013 Year 07 Month 01 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
2016 Year 01 Month 05 Day
Last modified on
2016 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023505


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