UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013031 |
|---|---|
| Receipt number | R000015209 |
| Scientific Title | Neoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2022/09/27 09:41:14 |
* 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
Neoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study
Acronym
HOPS-R01
Scientific Title
Neoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study
Scientific Title:Acronym
HOPS-R01
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and the efficacy of neoadjuvant S-1 therapy for resectable pancreatic cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Two year progression free survival
Key secondary outcomes
Two year overall survival, Resection rate, Pathological effect, Response rate, Adverse effect, Surgical complication
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 |
Interventions/Control_1
S-1:80mg/day(BSA<1.25/m2)
100mg/day(1.25/m2=<BSA<1.5/m2)
120mg/day(BSA=>1.5/m2), day1-28.
1 cycle 6weeks, repeat 2 cycles before 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pathologically or cytologically proven diagnosis of pancreas cancer.
2) Definition of a Resectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma
3) Without distant metastasis
4) Patients of age =>20
5) Performance Status:0-1 (ECOG)
6) Adequate oral intake
7) Good main organ function
8) Written informed consent
Key exclusion criteria
1) Treatment history of S-1
2) Treatment history of a pancreatic cancer
3) Regular use of frucitocin, fenitoin or warfarin
4) Patients who can' t receive neither iodic drug because of drug allergy
5) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings
6) Massive pleural or abdominal effusion
7) Severe infection
8) Watery diarrhea
9) Uncontrolled diabetes
10) Simultaneous or metachronous (within 3 years) double cancers
11) Hemorrhagic peptic ulcer
12) Patients with severe disease
13) Patients requiring systemic steroids medication
14) Severe mental illness
15) Severe drug hypersensitivity
16)Pregnant females, possibly pregnant females, females wishing to become pregnant or Males that are currently attempting to produce a pregnancy
17)Patients seems inadequate for this study by investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hirano |
Organization
Hokkaido University
Division name
Gastroenterological Surgery II
Zip code
060-8638
Address
N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7714
satto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Nakamura |
Organization
Hokkaido University
Division name
Gastroenterological Surgery II
Zip code
060-8638
Address
N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7714
Homepage URL
torunakamura@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Pancreatic Cancer Study Group (HOPS)
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
Institutional review board of Hokkaido University Hospital
Address
N14, W5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.huhp.hokudai.ac.jp/
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-022-14094-0
Number of participants that the trial has enrolled
51
Results
2year disease free survival
ITT(N=49):40.8%
2year disease free survival
Resection(N=43):46.5%
2year overall survival
ITT(N=49):73.2%
2year overall survival
Resection(N=43):76.7%
Results date posted
| 2019 | Year | 03 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age(y.o):median 71(range 47-83)
Gender(male/female):23/28
Pancreatic head/body:32/19
Participant flow
80 patients:Resectable over 20y.o., PS 0-1
51 patients:enrolled
49 patients:eligible
33 patients:operation
31 patients:resection
Adverse events
Grade
3/4, n (%)
Hematological
Anemia 1 (2.0)
Leukopenia 2 (4.1)
Neutropenia 4 (8.2)
Thrombocytopenia 1 (2.0)
Nonhematological
Fatigue 1 (2.0)
Diarrhea 5 (10.2)
Anorexia 2 (4.1)
Nausea 2 (4.1)
Vomiting 2 (4.1)
Mucositis 0
Hyperpigmentation 0
Dermatitis 0
Cholangitis 3 (6.1)
Pulmonary embolism 1 (2.0)
Outcome measures
2year disease free survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 31 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015209
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
