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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001038
Receipt No. 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

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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
Email 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/
Email tkosuge@ncc.go.jp

Sponsor
Institute Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001168

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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