UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016436 |
|---|---|
| Receipt number | R000019090 |
| Scientific Title | A phase I/II clinical trial of carbon ion radiotherapy with concurrent S-1 for operable pancreatic cancer(HIMAT1325) |
| Date of disclosure of the study information | 2015/02/05 |
| Last modified on | 2018/10/24 17:20:57 |
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Basic information
Public title
A phase I/II clinical trial of carbon ion radiotherapy with concurrent S-1 for operable pancreatic cancer(HIMAT1325)
Acronym
Preoperative carbon-ion radiotherapy with S-1 chemotherapy for operable pancreatic cancer
Scientific Title
A phase I/II clinical trial of carbon ion radiotherapy with concurrent S-1 for operable pancreatic cancer(HIMAT1325)
Scientific Title:Acronym
Preoperative carbon-ion radiotherapy with S-1 chemotherapy for operable pancreatic cancer
Region
| Japan |
Condition
Condition
operable pancreatic 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 safety and efficacy of carbon-ion radiotherapy with S-1 chemotherapy for operable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase 1: normal tissue effect during observation period
Phase 2: local control rate
Key secondary outcomes
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
| Medicine | Device,equipment | Other |
Interventions/Control_1
Carbon-ion radiotherapy
Chemotherapy (S-1)
Surgery
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Stage I-IIB (UICC)
2)Pathologically diagnosed pancreatic invasive ductal carcinoma
3)No past history of treatment for pancreatic cancer
4)Planning target volume is less than 15cm
5)include evaluable lesion
6)Age under 75 years old
7)P 0-1
8)Sufficient major organ function
9)Informed consent by patient
Key exclusion criteria
1)Metallic stent at the bile duct
2)Invasion to mucosal membrane of stomach or intestine
3)Use of flu cytosine, phenytoin, or warfarin potassium
4)Past history of irradiation to the target region
5)Active double cancers
6)Uncontrolled severe infection
7)Uncontrolled severe complication
8)Other medical or psychological unsuitable reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
SAGA HIMAT Foundation
Division name
Ion Beam Therapy Center
Zip code
Address
3049, Harakoga-machi, Tosu, Saga, 841-0077
TEL
0942-81-1897
shioyama-yoshiyuki@saga-himat.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Terashima |
Organization
SAGA HIMAT Foundation
Division name
Ion Beam Therapy Center
Zip code
Address
3049, Harakoga-machi, Tosu, Saga, 841-0077
TEL
0942-81-1897
Homepage URL
terashima-kotaro@saga-himat.jp
Sponsor or person
Institute
Ion Beam Therapy Center
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 02 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019090
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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