UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014625 |
|---|---|
| Receipt number | 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 12:04:05 |
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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
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=R000017015
