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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002329
Receipt No. R000002842
Scientific Title Study on preoperative concurrent chemoradiotherapy with S-1 in oral cancer (Phase II study)
Date of disclosure of the study information 2009/08/18
Last modified on 2014/08/12

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Basic information
Public title Study on preoperative concurrent chemoradiotherapy with S-1 in oral cancer (Phase II study)
Acronym Study on preoperative concurrent chemoradiotherapy with S-1 in oral cancer (Phase II study)
Scientific Title Study on preoperative concurrent chemoradiotherapy with S-1 in oral cancer (Phase II study)
Scientific Title:Acronym Study on preoperative concurrent chemoradiotherapy with S-1 in oral cancer (Phase II study)
Region
Japan

Condition
Condition Oral cancer
Classification by specialty
Radiology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate both of the tumor reduction and the safety of preoperative chemoradiotherapy with S-1 in advanced oral cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Tumor reduction 4 weeks after chemoradiotherapy
Key secondary outcomes Adverse events on chemoradiotherapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 The total 40Gy of irradiation is delivered to both primary site and metastasized neck region. Chemotherapy regimen consisted of 5-day S-1 consecutive administration, followed by 2-day rest for 4 weeks.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria The cases with advanced oral cancer, the cases with no previous treatment
Key exclusion criteria The cases who have simultaneously another cancer, the cases who have severe complication in their body
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Omura
Organization Graduate School, Tokyo Medical and Dental University
Division name Oral and Maxillofacial Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5506
Email omura.osur@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Nakayama
Organization Graduate School, Kumamoto university
Division name Oral & Maxillofacial Surgery
Zip code
Address 1-1-1, Honjyo, Chuo-ku, Kumamoto
TEL 096-373-5288
Homepage URL
Email hinakaya@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute Oral and Maxillofacial Surgery, Graduate School, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2009 Year 08 Month 18 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
2009 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 12 Day
Last modified on
2014 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002842

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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