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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014625
Receipt No. R000017015
Scientific Title For advanced or recurrent esophageal cancer Of combination therapy - docetaxel-cisplatin-5 fluorouracil phase I/II trial
Date of disclosure of the study information 2014/07/23
Last modified on 2017/01/23

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Basic information
Public title For advanced or recurrent esophageal cancer
Of combination therapy - docetaxel-cisplatin-5 fluorouracil
phase I/II trial
Acronym Bi-weekly DCF therapy for esophageal cancer PI/II study
Scientific Title For advanced or recurrent esophageal cancer
Of combination therapy - docetaxel-cisplatin-5 fluorouracil
phase I/II trial
Scientific Title:Acronym Bi-weekly DCF therapy for esophageal cancer PI/II study
Region
Japan

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

Objectives
Narrative objectives1 Consider safety fluorouracil in combination therapy (DCF therapy), optimum dosage, effectiveness - docetaxel, cisplatin, 5-fluorouracil intended for advanced or recurrent esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint
estimate the optimal dose of docetaxel in combination therapy in CF.
consider kind of side effects, the severity.
Secondary endpoints
To examine the anti-tumor effect and incidence of adverse events.
Key secondary outcomes

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 docetaxel cisplatin 5-Fu
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with evaluable lesions or measurable
Patients have been identified with esophageal cancer histologically
Case found that there is no effect of previous treatment.
Key exclusion criteria Cases with (heart disease, interstitial pneumonitis or pulmonary fibrosis, and cirrhosis of the liver) complications serious.
patients with serious infections
Patients with edema required
Treatment Cases with non-pleural effusion control, ascites
Patients with a history of drug hypersensitivity serious.
Cases there is a possibility that pregnant women, pregnant and lactating women.
Cases is determined participation in the test is difficult and complicated by psychiatric symptoms or psychosis
Patients undergoing (oral or intravenous) systemic continuous administration ofsteroid
Cases attending physician was deemed inappropriate In carrying out Other, this clinical trial.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Tanaka
Organization Gifu University
Division name Surgical Oncology
Zip code
Address 1-1 Yanagido Gifu City
TEL 0582306000
Email yoshihirotana11@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Tanaka
Organization Gifu University
Division name Surgical Oncology
Zip code
Address 1-1 Yanagido Gifu City
TEL 0582306000
Homepage URL
Email yoshihirotana11@hotmail.com

Sponsor
Institute gifu University
Institute
Department

Funding Source
Organization self-funding
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
2014 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2009 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 07 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
2014 Year 07 Month 23 Day
Last modified on
2017 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017015

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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