UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010383 |
|---|---|
| Receipt number | R000012075 |
| Scientific Title | Phase I study of combination therapy with endoscopic triamsinolone injection and fluticasone swallowing for the prevention of esophageal stricture after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/10/28 22:57:23 |
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Basic information
Public title
Phase I study of combination therapy with endoscopic triamsinolone injection and fluticasone swallowing for the prevention of esophageal stricture after endoscopic submucosal dissection
Acronym
Phase I study of combination therapy with endoscopic triamsinolone injection and fluticasone swallowing for the prevention of esophageal stricture after endoscopic submucosal dissection
Scientific Title
Phase I study of combination therapy with endoscopic triamsinolone injection and fluticasone swallowing for the prevention of esophageal stricture after endoscopic submucosal dissection
Scientific Title:Acronym
Phase I study of combination therapy with endoscopic triamsinolone injection and fluticasone swallowing for the prevention of esophageal stricture after endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of combination therapy with endoscopic triamsinolone injection and fluticasone swallowing for the prevention of esophageal stricture after endoscopic submucosal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Proportion of dose limiting toxicity (DLT)
Key secondary outcomes
Proportion of adverse events
Rate of esophageal stricture
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
Combination therapy with endoscopic triamsinolone injection and fluticasone swallowing
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) Histologically proven esophageal cancer.
2)Without distant metastasis.
3)More than 1/2 luminal circumferencial esophageal cancer.
4)Aged upper 20 years old.
5)ECOG Performance status 0 or 1.
6)Without history of radiotherapy for neck, chest, and upper abdominal region.
7)Without history of surgical treatment of esophagus (except endoscopic treatmenet).
8)Written informed consent.
Key exclusion criteria
1)Pregnant or lacting women.
2)Active infection.
3)Psychosis.
4)Simulataneous double cancers.
5)Severe diabetes mellitus.
6)Patients who have been judged as inappropriate for this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Doyama |
Organization
Ishikawa prefectural central hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1 Kuratukihigashi Kanazawa-shi Ishikawa-ken
TEL
076-237-8211
doyama.134@ipch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiro Yoshida |
Organization
Ishikawa prefectural central hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1 Kuratukihigashi Kanazawa-shi Ishikawa-ken
TEL
076-237-8211
Homepage URL
naohilow@yahoo.co.jp
Sponsor or person
Institute
Ishikawa prefectural central hospital
Institute
Department
Personal name
Funding Source
Organization
Ishikawa prefectural central hospital
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
| 2013 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012075
