UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011179 |
|---|---|
| Receipt number | R000012997 |
| Scientific Title | Phase II study of 3-weeks cycle of S-1 as first-line for advanced pancreatic cancer (PACS-3) |
| Date of disclosure of the study information | 2013/07/12 |
| Last modified on | 2018/01/14 21:26:09 |
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Basic information
Public title
Phase II study of 3-weeks cycle of S-1 as first-line for advanced pancreatic cancer (PACS-3)
Acronym
3-weeks cycle of S-1 for pancreatic cancer (PACS-3)
Scientific Title
Phase II study of 3-weeks cycle of S-1 as first-line for advanced pancreatic cancer (PACS-3)
Scientific Title:Acronym
3-weeks cycle of S-1 for pancreatic cancer (PACS-3)
Region
| Japan |
Condition
Condition
advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of 3-weeks cycle of S-1 as first-line chemotherapy for advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival
Response rate
Safety
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
TS-1 will be orally administered twice daily (after breakfast and supper) for 14 consecutive days at one of the doses (50mg, 80 mg, 100 mg, 120 mg/day) adjusted for body surface area, then withdrawn for 7 days. One cycle consists of 21 days and administration will be continued until patients satisfy any of the conditions for discontinuation of the study treatment.
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) Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma.
2) Advanced unresectable pancreatic cancer.
3) Patients with no previous treatment (radiotherapy, chemotherapy etc) for pancreatic cancer, except resection.
4) Age: between 20 and 79 years at registration.
5) ECOG Performance Status (PS) of 0 or 1.
6) Sufficient function of major organs as defined below.
White blood cell count: 3500/mm3
Neutrophil count: 2000/mm3
Hemoglobin: 9.0 g/dL
Platelet count: 100000/mm3
Total bilirubin: 2.0 mg/dL
AST and ALT: 150 U/L
Serum creatinine: 1.2 mg/dL
Creatinine clearance: 50mL/min
7) Able to take capsules orally.
8) No clinically abnormal ECG findings within 28 days before registration.
9) Voluntarily signed the written consent form.
Key exclusion criteria
1) Pulmonary fibrosis or interstitial pneumonia.
2) Watery diarrhoea.
3) Active infections, excluding viral hepatitis.
4) Serious complications (e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
5) Moderate or severe ascites or pleural effusion requiring treatment.
6) Metastasis in the CNS.
7) Active double cancer.
8) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
10) Severe mental disorder.
11) Judged ineligible by physicians for participation in the study from a safety viewpoint.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University graduate school of medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-230-6308
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinpei Doi |
Organization
Gifu University graduate school of medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-230-6308
Homepage URL
doisin@nifty.com
Sponsor or person
Institute
Gifu 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
Gifu Prefectural Medical Center
Gifu Municipal Hospital
Kurume University Hospital
Japanese Red Cross Nagoya Daini Hospital
Nagoya City University Hospital
Mie University Hospital
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
岐阜大学医学部附属病院（岐阜県）
岐阜県総合医療センター（岐阜県）
岐阜市民病院（岐阜県）
久留米大学医学部附属病院（福岡県）
名古屋第二赤十字病院（愛知県）
名古屋市立大学医学部附属病院（愛知県）
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 12 | Day |
Last modified on
| 2018 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012997
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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