UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002329 |
|---|---|
| Receipt number | 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 18:40:09 |
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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
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
hinakaya@fc.kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Oral and Maxillofacial Surgery, Graduate School, Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002842
