UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006195 |
|---|---|
| Receipt number | R000007309 |
| Scientific Title | Phase 1 study of once-daily and alternate-day oral administration of S-1 in patients with locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer |
| Date of disclosure of the study information | 2011/08/18 |
| Last modified on | 2014/05/08 14:38:42 |
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Basic information
Public title
Phase 1 study of once-daily and alternate-day oral administration of S-1 in patients with locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer
Acronym
Phase 1 study of once-daily and alternate-day oral administration of S-1 in patients with locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer
Scientific Title
Phase 1 study of once-daily and alternate-day oral administration of S-1 in patients with locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer
Scientific Title:Acronym
Phase 1 study of once-daily and alternate-day oral administration of S-1 in patients with locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer
Region
| Japan |
Condition
Condition
locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the safety of once-daily and alternate-day oral administration of S-1. To determinate recommended dose in subsequent studies.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The incidence of adverse event and Dose-Limiting Toxicity(DLT).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of the following dose once-a-day after breakfast on Sunday, Monday, Wednesday, and Friday for 6 weeks.
Body surface area (BSA) <1.25 m2 : 100mg
1.25 m2<= BSA <1.5 m2 : 120mg
1.50 m2<= BSA : 150mg
Interventions/Control_2
Oral administration of the following dose once-a-day after breakfast on Sunday, Monday, Wednesday, and Friday for 6 weeks.
BSA <1.25 m2 : 120mg
1.25 m2<= BSA <1.5 m2 : 150mg
1.50 m2<= BSA : 175mg
Interventions/Control_3
Oral administration of the following dose once-a-day after breakfast on Sunday, Monday, Wednesday, and Friday for 6 weeks.
BSA <1.25 m2 : 150mg
1.25 m2<= BSA <1.5 m2 : 175mg
1.50 m2<= BSA : 200mg
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) Invasive pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or adenosquamous carcinoma.
2) Locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer. Having of measurable lesions must not be required.
3) Patients with no previous treatment (radiotherapy, chemotherapy,immunotherapy, etc.) for pancreatic cancer, except resection.
4) Patients must be >=20 years old and <=80 years old at the time of consent.
5) ECOG Performance Status must be 0 or 1.
6) The following criteria must be satisfied in laboratory tests conducted within 21 days before enrollment.
-White blood cell count >=3,500 /mm3 ,<=12,000/mm3
-Neutrophil count >=2,000 /mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=100,000 /mm3
-Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
-AST <=150 IU/L
-ALT <=150 IU/L
-Serum Creatinine <=1.2 mg/dL
-Creatinine Clearance >= 60 mL/min
7) Oral intake is possible.
8) Clinically normal ECG within 28 days before registration.
9) Patient must have signed the consent form.
Key exclusion criteria
1) Interstitial pneumonia or pulmonary fibrosis.
2) Watery diarrhea.
3) Severe infections (without viral hepatitis) or being suspected (fever evaluation >=38 degrees).
4) Serious complication (heart failure, renal disorder, liver disorder, bleeding digestive ulcer, intestinal tract paralysis, and etc. ).
5) Moderate or greater pleural effusion, ascites fluid (requiring drainage).
6) Cerebral metastasis.
7) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 year) except carcinoma in situ or intramucosal cancer.
8) Patients who require administration of flucytosine, phenytoin, and warfarin.
9) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period.
10) Serious mental disorder.
11) Drug hypersensitivity.
12) Patients who are judged by doctors inappropriate to perform the study safely.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoki Miyazawa |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-477-2300
Homepage URL
mo-0702@wakayma-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 08 | Month | 18 | 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
| 2011 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 09 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 18 | Day |
Last modified on
| 2014 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007309
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