UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010922 |
|---|---|
| Receipt number | R000012780 |
| Scientific Title | Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer |
| Date of disclosure of the study information | 2013/06/11 |
| Last modified on | 2019/06/16 08:53:23 |
* 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
Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer
Acronym
HORE PC01
Scientific Title
Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer
Scientific Title:Acronym
HORE PC01
Region
| Japan |
Condition
Condition
Resected pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the clinical effectiveness of the S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for the patients with pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
treatment complete rate
Key secondary outcomes
Relapse free survival, overall survival, Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1by Alternate day administration for 180days (6months) (1 course=6weeks, 42days).
Interventions/Control_2
S-1 for 28 days with 14 days rest for 180days (6months) (1 course=6weeks, 42days).
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) Resected cases with histologically proven invasive ductal carcinoma of the pancreas
2) According to the UICC classification,
a) Stage I or II, or III in whom celiac artery resection was performed
b) R0 or R1
c) Cancer negative for washing cytology of the abdominal cavity
3) No distant metastasis nor malignant ascites
4) Adequate oral intakes
5) Aged 20 years or older
6) An Eastern Cooperative Oncology Group performance status of 0 or 1
7) No prior history of chemotherapy nor radiation therapy within three years
8) Within 10 weeks after operation
9) Sufficient organ function
10) Written informed consent
Key exclusion criteria
1) Prior history of S-1 therapy
2) Recurrent disease on enrollment
3) Massive ascites or pleural effusion
4) Plumonary fibrosis or interstitial pneumonia
5) Severe diarrhea
6) Severe infection
7) Blood transfusion within two weeks
8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc
9) Severe mental disorder
10) Severe drug allergy
11) Other active malignancy
12) Pregnancy, breast feeding, or women who desire to preserve fecundity or Men who desire to have children
13) Regular use of frucitocin, fenitoin or warfarin
14) Inadequate physical condition, as diagnosed by primary physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Konno |
Organization
Hamamatsu University School of Medicine
Division name
Second Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
TEL
053-435-2279
kon_6416@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Sakaguchi |
Organization
Hamamatsu University School of Medicine
Division name
Second Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
TEL
053-435-2279
Homepage URL
saka1119@hama-med.ac.jp
Sponsor or person
Institute
HORE
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
iwata city hospital
Hamamatsu medical center
shizuoka city shimizu hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1, Handayama Hamamatsu Shizuoka 431-3192
Tel
053-435-2111
rinri@hama-med.ac.jp
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
静岡
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 10 | Day |
Last modified on
| 2019 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012780
