UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013133 |
|---|---|
| Receipt number | R000015315 |
| Scientific Title | Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2019/08/17 21:48:03 |
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Basic information
Public title
Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Acronym
Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Scientific Title
Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Scientific Title:Acronym
Efficacy of sodium alginate in patients with acute radiation esophagitis; randomized trial
Region
| Japan |
Condition
Condition
locally advanced non-small-cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An aim of this study is to confirm incidence of the radiation esophagitis when we used sodium alginate in an early stage or the close for a case to be given lung cancer chemoradiation simultaneous combination therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Esophagitis incidence grade 3 or more based on CTCAE v4.0
Key secondary outcomes
responce rate
progression free survival
overall survival
Other adverse events
Use ratio of analgesic
quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
take sodium alginate for start of therapy
Interventions/Control_2
take sodium alginate after symptom onset
Interventions/Control_3
take the water which cooled off to 4 degrees Celsius for start of therapy
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
Histologically or cytologically confirmed non-small-cell lung cancer
Disease stage is IIIA/B period which is available for radical irradiation.
ECOG performance status of 0 or 1
the case that we can ingest
Adequate bone marrow function
WBC 4,000/cmm or more; PLT 100,000/cmm or more
Adequate liver function
T Bil 1.5 mg/dl or less; GOT and GPT 2.5 times the upper limit of normal at each institution
Adequate kidney function
Creatinine 1.5 mg/dl or less; Ccr 60 ml/min or more
Adequate pulmonary function
Pa02 60 Torr or more
However, this will not apply if there is reduced respiratory function due to stenosis of a main bronchus or a lobar bronchus, and it can be expected that resolution of the stenosis will lead to rapid improvement.
Acquisition of written informed consent
Key exclusion criteria
the case that esophagus is not included in the fields in radiation treatment planning
the case with atelectasis of the lung unilateral before treatment
the case that has difficulty in oral internal use
the case with serious complications
the case that there is a history of treatment of esophageal cancer and the gastric cancer, and esophageal reconstruction is done
the case with the reflux oesophagitis of the clear activity
Pregnant woman, nursing mother, the women who may be pregnant, the women with the will or the men who hope for fertility with pregnancy
the case that takes sodium alginate
the case (when, however, it can be discontinued for condition possible registration) that takes proton pump inhibitor (PPI) regularly
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Kiura |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-2357-227
kkiura@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiichiro |
| Middle name | |
| Last name | Ninomiya |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7227
Homepage URL
doctor_kirou@hotmail.com
Sponsor or person
Institute
Okayama Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
岡山大学病院（岡山県）
倉敷中央病院（岡山県）
公立学校共済組合 中国中央病院（広島県）
医療法人 住友別子病院（愛媛県）
国家公務員共済組合連合会 呉共済病院（広島県）
岡山赤十字病院（岡山県）
川崎医科大学附属川崎病院（岡山県）
愛媛県立中央病院（愛媛県）
津山中央病院（岡山県）
福山市民病院（広島県）
尾道市民病院（広島県）
鳥取市立病院（鳥取県）
独立行政法人国立病院機構 南岡山医療センター（岡山県）
独立行政法人国立病院機構 四国がんセンター（愛媛県）
独立行政法人国立病院機構 山口宇部医療センター（山口県）
独立行政法人国立病院機構 岡山医療センター（岡山県）
独立行政法人国立病院機構 福山医療センター（広島県）
独立行政法人労働者健康福祉機構 岡山労災病院（岡山県）
独立行政法人労働者健康福祉機構 香川労災病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 11 | Day |
Last modified on
| 2019 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015315
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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