UMIN-CTR Clinical Trial

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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