UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017573 |
|---|---|
| Receipt number | R000020363 |
| Scientific Title | S-1(DGS), nedaplatin, and cetuximab chemotherapy for advanced or recurrent head and neck cancer: a phase I/II study. |
| Date of disclosure of the study information | 2015/05/15 |
| Last modified on | 2016/11/14 19:39:54 |
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Basic information
Public title
S-1(DGS), nedaplatin, and cetuximab chemotherapy for advanced or recurrent head and neck cancer: a phase I/II study.
Acronym
S-1(DGS), nedaplatin, and cetuximab chemotherapy for advanced or recurrent head and neck cancer: a phase I/II study.
Scientific Title
S-1(DGS), nedaplatin, and cetuximab chemotherapy for advanced or recurrent head and neck cancer: a phase I/II study.
Scientific Title:Acronym
S-1(DGS), nedaplatin, and cetuximab chemotherapy for advanced or recurrent head and neck cancer: a phase I/II study.
Region
| Japan |
Condition
Condition
advanced or recurrent head and neck carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety/efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
general condition
tumor marker
CT,MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
over 20 age and under 80 age
Key exclusion criteria
drug allergy history
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Torahiko Nakashima |
Organization
Kyushu University
Division name
Otorhinolaryngology
Zip code
Address
3-1-1 Maidashi, Fukuoka
TEL
092-642-5668
nakatora@qent.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuji Yasumatsu |
Organization
Kyushu University
Division name
Otorhinolaryngology
Zip code
Address
3-1-1 Maidashi, Fukuoka
TEL
092-642-5668
Homepage URL
yasuryuj@qent.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of ORL, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of ORL, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 05 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020363
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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