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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009150
Receipt No. R000010727
Scientific Title Feasibility study of agjuvant chemotherapy with docetaxel, cisplatin and fluorouracil for esophageal cancer
Date of disclosure of the study information 2012/10/19
Last modified on 2014/01/22

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Basic information
Public title Feasibility study of agjuvant chemotherapy with docetaxel, cisplatin and fluorouracil for esophageal cancer
Acronym Feasibility study of agjuvant chemotherapy for esophageal cancer
Scientific Title Feasibility study of agjuvant chemotherapy with docetaxel, cisplatin and fluorouracil for esophageal cancer
Scientific Title:Acronym Feasibility study of agjuvant chemotherapy for esophageal cancer
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is elucidate the anticancer efficacy and feasibility of docetaxel, cisplatin and fluorouracil for advanced esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Completion rate of 2 cycles
Key secondary outcomes Adverse event
Adverse eventProgression free survival
Overall 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 docetaxel(70mg/m2/day) day1
cisplatin(70mg/m2/day1) day1
5-fluorouracil(700mg/m2/day) day1-5
q4w, 2 cycle
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 1,5)Patients with esophageal SCC who underwent currative (R0) resection without preoperative treatment and had pathological LN metastases

2)TNM stage 2 and 3
3)Age of 20 to 74 years with either gender and ECOG Performance Status of 0 to 2
4)No past history of chemotherapy, irradiation and operation for esophageal cancer
6)Laboratory values as follows
4000/mm3 < WBC < 12000mm3
2000/mm3 < Nuetrophil
100000/mm3 < Platelet count
9.0g/dL Hemoglobin
AST,ALT < 2.0 times of normal upper
limits
Serum creatinine < 1.2mg/dL
60ml/min < Cleatinine clearance

7)Written informed consent
Key exclusion criteria 1) Past history of drug allergy
2)Past history of drug allergy of
docetaxel, cisplati and fluorouracil
3)Patient with clinically obvious
infecton
4)Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
5)Disease that is serious or requires hospitalization, or history of such disease within past year
6)Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage
7)Massive pleural effusion, ascites and pericardial effusion
8)Gastrointestinal hemorrhage
9)Chronic diarrhea (watery stool or 4 times or more/day)
10)Active hepatitis type HBs positive
11)More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
12)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Hirahara, M.D., Ph.D.
Organization Shimane University Hospital
Division name Digestive and General Surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
TEL 0853-20-2232
Email norinori@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Hirahara, M.D., Ph.D.
Organization Shimane University Hospital
Division name Digestive and General Surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
TEL 0853-20-2232
Homepage URL
Email norinori@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 島根大学附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 19 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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 19 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 10 Month 19 Day
Last modified on
2014 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010727

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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