UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014070 |
|---|---|
| Receipt number | R000016379 |
| Scientific Title | Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2021/05/31 09:04:41 |
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Basic information
Public title
Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma
Acronym
Adjuvant chemotherapy for salivary gland carcinoma
Scientific Title
Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma
Scientific Title:Acronym
Adjuvant chemotherapy for salivary gland carcinoma
Region
| Japan |
Condition
Condition
Salivary gland carcinoma
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess whether adjuvant chemotherapy using TS-1 can improve prognosis in the patients with salivary gland carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Overall survival time
Key secondary outcomes
Disease free survival time, Distant metastasis free survival time, adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant chemotherapy (TS-1, one year)
Interventions/Control_2
no adjuvant chemotherapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Proven salivary gland carcinoma
2) Having primary site in the oral and maxillofacial region excepting the parotid gland
3) Patients who underwent radical treatment with surgery
4) No evidence of distant metastasis
5) 20 years <=, <= 80 years old
6) ECOG performance status 0 or 1
7) Registration within 3 months after the primary treatment
8) No previous chemo- or radiotherapy (excepting salivary Ca).
9) Good and fair condition of major organs.
10) Possible of oral administration
11) Written informed consent.
Key exclusion criteria
1) The possibility (will) of the pregnancy and nursing girl
2) Active multiple primary
3) Having a mental disorder
4) Having a serious or life-threatening disease.
5) Having uncontrolled diarrhea
6) Systemic steroid use
7) Having infection
8) Having fever up over 38 degree Celsius
9) Severe allergic reaction for any drugs
10) Taking flucytosine
11) Patients who need flucytosine, phenytoin, or warfarin.
12) Anyone who was judged as unsuitable for this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kurita |
Organization
Shinshu University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
Asahi 3-1-1, Matsumoto
TEL
0263-37-2677
hkurita@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kurita |
Organization
Shinshu University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
Asahi 3-1-1, Matsumoto
TEL
0263-37-2677
Homepage URL
hkurita@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Dentistry and Oral Surgery, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Dentistry and Oral Surgery, Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
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 | 06 | 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 | 05 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 26 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016379
