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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014070
Receipt No. 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 2014/05/26

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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
Email 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
Email hkurita@shinshu-u.ac.jp

Sponsor
Institute Department of Dentistry and Oral Surgery, Shinshu University School of Medicine
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2014 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 06 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
2014 Year 05 Month 26 Day
Last modified on
2014 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016379

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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