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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007875
Receipt No. R000008356
Scientific Title Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment
Date of disclosure of the study information 2012/05/01
Last modified on 2017/10/03

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Basic information
Public title Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment
Acronym FOLFOX for GEM/S1 refractory pancreatic cancer
Scientific Title Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment
Scientific Title:Acronym FOLFOX for GEM/S1 refractory pancreatic cancer
Region
Japan

Condition
Condition unresectable or recurrent pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility and efficacy of modified FOLFOX6 therapy for unresectable or recurrent pancreatic cancer which is refractory for gemcitabine and S1
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Feasibility (treatment continuation rate for 3 course)
Overall survival
Key secondary outcomes Response rate, Progression free survival, Adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 modified FOLFOX6 therapy against gemcitabine and S1 refractory pancreatic cancer
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. Histologically confirmed pancreatic adenocarcinoma
2. Unresectable or recurrent disease
3. Gemcitabine and S-1 refractory
4. Age over 20
5. ECOG PS=0, 1, 2
6. Life expectancy over 12 weeks
7. Well controlled sympton
8. Needs adequate organ function
9. Written informed consent
Key exclusion criteria 1. Uncontrollable diarrhea
2. Administration of phenytoin, warfarin, flucytosine
3. Pleural effusion, Ascites
4. Active serious infection
5. Active multiple cancer
6. Active peptic ulcer
7. Serious complication
8. Serious mental disorder
9. Serious drug allergy
10. Pregnancy woman, or woman with suspected pregnancy
11. Any subject judged by the investigator to be unfit for any reason to participate in the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuyuhiko Motoi
Organization Tohoku University Hospital
Division name Division of hepato-biliary pancreatic surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Email fmotoi@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuyuhiko Motoi
Organization Tohoku University Hospital
Division name Division of hepato-biliary pancreatic surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Homepage URL http://www.surg1.med.tohoku.ac.jp/
Email fmotoi@surg1.med.tohoku.ac.jp

Sponsor
Institute Division of hepato-biliary pancreatic surgery, Tohoku University (Graduate School of Medicine)
Institute
Department

Funding Source
Organization Division of hepato-biliary pancreatic surgery, Tohoku University (Graduate School of Medicine)
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
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
2012 Year 05 Month 01 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 Completed
Date of protocol fixation
2012 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2016 Year 05 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
2012 Year 05 Month 01 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008356

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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