UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003453 |
|---|---|
| Receipt number | R000004174 |
| Scientific Title | Phase II study of alternate-day administrations of S-1 as 1st-line treatment in patients with metastatic and locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2010/04/06 |
| Last modified on | 2014/10/06 16:46:02 |
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Basic information
Public title
Phase II study of alternate-day administrations of S-1 as 1st-line treatment in patients with metastatic and locally advanced pancreatic cancer
Acronym
Phase II study of alternate-day administrations of S-1 as 1st-line treatment in patients with metastatic and locally advanced pancreatic cancer
Scientific Title
Phase II study of alternate-day administrations of S-1 as 1st-line treatment in patients with metastatic and locally advanced pancreatic cancer
Scientific Title:Acronym
Phase II study of alternate-day administrations of S-1 as 1st-line treatment in patients with metastatic and locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
Metastatic or locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of alternate-day S-1 administration for 1st-line metastatic and locally advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Time to Treatment Failure, Disease Control Rate, Adverse Events, Administration Rate of S-1
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
Alternate-day administrations of S-1
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)Histologically confirmed pancreatic cancer as adenocarcinoma or adenosquamous carcinoma
2)Non-resectable and confirmed target region
3)No prior treatment
4)Age 20-79
5)PS 0/1
6)Adequate organ functions
neutrophils >=2,000/mm3
leukocytes >=3,500/mm3
platelets >=100,000/mm3
hemoglobin >=9.0g/dL
AST(GOT)/ALT(GPT) <=150IU/L
total bilirubin <=2.0mg/dL
serum creatinine <=1.2mg/dL
creatinine clearance >=60mL/min
7)Sufficient oral intake
8)Normal ECG
9)Written informed concent
Key exclusion criteria
1)Symptomatic pulmonary fibrosis or interstitial pneumonia
2)Severe diarrhea
3)Active infection
4)Severe complications, such as ileus, heart failure and renal failure
5)Marked pleural or peritoneal effusion
6)Metastasis in central nervous system
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)History of severe anaphylaxies
12)Inadequate physical condition, as diagnosed by primary physician
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Homepage URL
Sponsor or person
Institute
Pancreatic Cancer Treatment Research Group
Institute
Department
Personal name
Funding Source
Organization
Pancreatic Cancer Treatment Research Group
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
| 2010 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 06 | Day |
Last modified on
| 2014 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004174
