UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001038 |
|---|---|
| Receipt number | R000001168 |
| Scientific Title | Multicenter phase I/II trial of adjuvant combination chemotherapy with gemcitabine and S-1 for pancreatic cancer |
| Date of disclosure of the study information | 2008/04/01 |
| Last modified on | 2015/02/19 18:44:50 |
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Basic information
Public title
Multicenter phase I/II trial of adjuvant combination chemotherapy with gemcitabine and S-1 for pancreatic cancer
Acronym
Phase I/II trial of adjuvant chemotherapy with gemcitabine and TS-1 for pancreatic cancer
Scientific Title
Multicenter phase I/II trial of adjuvant combination chemotherapy with gemcitabine and S-1 for pancreatic cancer
Scientific Title:Acronym
Phase I/II trial of adjuvant chemotherapy with gemcitabine and TS-1 for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I: to determine the maximum-tolerated dose and dose-limiting toxicity of GS therapy in patients with resected pancreatic cancer.
Phase II: to assess the efficacy and toxicity of GS therapy in patients with resected pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: the maximum-tolerated dose and dose-limiting toxicity of GS therapy.
Phase II: overall survival.
Key secondary outcomes
Phase II: adverse events and disease-free survival.
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
S1: bid d1-7 q2w x 12 courses PO
GEM: d1 q2w x 12 courses DIV
The doses of GEM and S-1 in the phase II trial are determined based on the results of the phase I trial.
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 proven pancreatic adenocarcinoma
2)Gross complete resection (R0 or R1)
3)No prior chemotherapy or radiotherapy
4)Age between 20 and 79 years
5)ECOG performance status of 0 or 1
6)Adequate hematologic, hepatic and renal function
7)Written informed consent
Key exclusion criteria
1)Watery diarrhea
2)Severe mental disorder
3)Active infection
4)Severe complications, such as ileus, heart failure and renal failure
5)Symptomatic pulmonary fibrosis or interstitial pneumonia
6)History of radiation therapy to the chest
7)Marked pleural or peritoneal effusion
8)Active concomitant malignancy
9)Treatment with phenytoin, potassium warfarin or flucytosine
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoo Kosuge |
Organization
National Cancer Center Hospital
Division name
HBP Surgery Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
tkosuge@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Kosuge |
Organization
Office of the Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
Division name
National Cancer Center Hospital, HBP Surgery Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
http://mhlw-grants.niph.go.jp/
tkosuge@ncc.go.jp
Sponsor or person
Institute
Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 18 | Day |
Last modified on
| 2015 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001168
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