UMIN-CTR Clinical Trial

Basic information
Public title	Effect of personnalized anticancer chemotherapy based on high precision molecular diagnosis on locoregional and hematogenous dissemination of oral squamous cell carcinoma
Acronym	Effect of personnalized anticancer chemotherapy on locoregional and hematogenous dissemination of oral squamous cell carcinoma
Scientific Title	Effect of personnalized anticancer chemotherapy based on high precision molecular diagnosis on locoregional and hematogenous dissemination of oral squamous cell carcinoma
Scientific Title:Acronym	Effect of personnalized anticancer chemotherapy on locoregional and hematogenous dissemination of oral squamous cell carcinoma
Region	Japan

Condition
Condition	Oral squamous cell carcinoma
Classification by specialty	Oral surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To assess the effect of personnalized anticancer chemotherapy based on high precision molecular diagnosis on locoregional and hematogenous dissemination of oral squamous cell carcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Over all survival
Key secondary outcomes	Disease free survival, Time to distant metastasis, Adverse effects

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Proven oral squamous cell carcinoma 2) To have a resectable lesion (T1-4a, N0-3) 3) No distant metastasis at first visit 4) ECOG performance status 0 or 1 5) No previous chemo- or radiotherapy. 6) WBC count 4,000/L, hemoglobin 10 g/L, platelet count 100,000/L, ALT and AST twice the upper limit of normal, bilirubin 1.5 and serum creatinine 1.2. 7) Written informed consent.
Key exclusion criteria	1) The possibility (will) of the pregnancy and nursing girl 2) Active multiple primary 3) Having a serious or life-threatening disease. 4) Having a mental disorder 5) Systemic steroid use 6) Having infection or fever up 7) Severe allergic reaction for any drugs 8) Edema (grade 2 and more) 9) Peripheral neuropathy (grade 2 and more)
Target sample size	140

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroshi Kurita
Organization	Shinshu university School of Medicine
Division name	Dentistry and Oral Surgery
Zip code
Address	Asahi 3-1-1, Matsumoto
TEL	0263-37-2677
Email	hkurita@shinshu-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroshi Kurita
Organization	Shinshu University School of Medicine
Division name	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	Dept. of Dentistry and Oral Surgery,Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Dept. 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	2013 Year 11 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	Preinitiation
Date of protocol fixation	2013 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date	2013 Year 11 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 09 Month 18 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013797