UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017715 |
|---|---|
| Receipt number | R000020523 |
| Scientific Title | Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2016/06/01 15:18:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer
Acronym
Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer
Scientific Title
Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer
Scientific Title:Acronym
Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to assess the safety of S-1 adjuvant therapy with propagermanium in patients with resected pancreatic cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
safety
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TS-1
<1.25m2, 80mg/body
1.25m2<and<1.5m2, 100mg/body
1.5m2<, 120mg/body
day1-28, q2w, x6
propagerumanium
30mg/day
day1-28, q2w, x6
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)Histologically proven pancreatic adenocarcinoma
2)Gross complete resection (R0)
3)Age above 20 years
4)Status of 0 or 1
5)Adequate hematologic, hepatic and renal function
6)Good oral intake
7)Start therapy after operation within 4 weeks later and 12 weeks
8)Written informed consent
Key exclusion criteria
1)Non curative operation
2)Active concomitant malignancy
3)History of severe anaphylaxies
4)Severe complications, such as heart failure, renal failure, liver failure, watery diarrhea, paresis of intestine, ileus and severe diabetes mellitus
5)With the jaundice or cirrhosis
6)Active infection
7)Pregnant or pregnant possibility
8)Severe mental disorder
9)Inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Osaka University Hospital
Division name
Division of HBP surgery and Transplantation
Zip code
Address
2-2 Yamadaoka E-2, Suita, Osaka
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisaku Yamada |
Organization
Osaka University Hospital
Division name
Division of HBP surgery and Transplantation
Zip code
Address
2-2 Yamadaoka E-2, Suita, Osaka
TEL
06-6879-3251
Homepage URL
dyamada@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 07 | Month | 01 | 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 | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2016 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020523
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
