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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014626
Receipt No. R000017016
Scientific Title DGS therapy for cervical esophageal carcinoma or cervical metastasis of esophageal carcinoma PI/II study
Date of disclosure of the study information 2014/07/23
Last modified on 2017/01/23

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Basic information
Public title DGS therapy for cervical esophageal carcinoma or cervical metastasis of esophageal carcinoma PI/II study
Acronym DGS therapy for esophageal cancer PI/II study
Scientific Title DGS therapy for cervical esophageal carcinoma or cervical metastasis of esophageal carcinoma PI/II study
Scientific Title:Acronym DGS therapy for esophageal cancer PI/II study
Region
Japan

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

Objectives
Narrative objectives1 Phase I test
combination with docetaxel in TS-1 and nedaplatin. The nedaplatin 40mg/m2, TS-determine the maximum tolerated dose of docetaxel, the optimal dose is fixed to 80mg/m2.
PhaseII trial
the safety and efficacy were observed to 20 cases in the optimum dosage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Study of efficacy and safety and the setting of optimal capacity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 DGS
Interventions/Control_2 DCF
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 cervical esophageal carcinoma or cervical metastasis of esophageal carcinoma
Key exclusion criteria Regardless of the adjuvant therapy, (tegafur, gimeracil, Oterashiru component of cases TS-capsule with a history of severe hypersensitivity to the 80-containing formulations polysorbate cases and docetaxel there is a treatment history TS-capsule, docetaxel, nedaplatin patients with a history of severe hypersensitivity to the formulation containing platinum or other cases nedaplatin with a history of severe hypersensitivity to the potassium)
Cases of disease-free period with active double cancer of less than 5 years
Cases (intestinal paralysis, intestinal obstruction, interstitial pneumonia, lung fibrosis, it is difficult to control diabetes, etc.) have a serious complication
Cases with active infection
Patients with edema requiring treatment
Pleural effusion requiring treatment, patients with ascites
Patients with a wide range of bone metastases
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=R000017016

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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