UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014626 |
|---|---|
| Receipt number | 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 12:03:00 |
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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
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
yoshihirotana11@hotmail.com
Sponsor or person
Institute
gifu university
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
