UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007556 |
|---|---|
| Receipt number | R000008872 |
| Scientific Title | A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer |
| Date of disclosure of the study information | 2012/03/23 |
| Last modified on | 2014/09/23 17:49:03 |
* 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
A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer
Acronym
GSL-1
Scientific Title
A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer
Scientific Title:Acronym
GSL-1
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the safety of combination therapy with gemcitabine and S-1 and leucovorin and determine the maximum tolerated dose and the recommended dose.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Dose limiting toxicity, maximum tolerated dose, recommended dose
Key secondary outcomes
Response rate, disease control rate, progression free survival, overall survival, 1-year survival rate, feasibility, 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
a combination therapy with gemcitabine, S-1 and leucovorin
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) Patients with unresectable pancreatic cancer without prior treatment
2) Patients with pathologically proven pancreatic cancer
3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
4) Patients of age >= 20 years
5) Patients who can eat
6) Patients have an adequate organ function defined as white cell count < 10,000/mm3, neutophils >=1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal
7) Estimated survival > 2months
8) Written informed consent is required from all patients.
Key exclusion criteria
1) Patients with systolic blood pressure < 100mmHg
2) Patients with an active concomitant infection
3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease
4) Patients with an active pulmonary fibrosis or interstitial pneumonia
5) Patients with severe diarrhea
6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
7) Patients with uncontrollable massive pleural effusion or massive ascites
8) Patients with an active concomitant malignancy
9) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
The University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1, Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
isayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yousuke Nakai |
Organization
University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
ynakai-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, Department of Gastroenterology
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
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
東京大学医学部附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25143299
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
Main results already published
Date of protocol fixation
| 2012 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 23 | Day |
Last modified on
| 2014 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008872
