UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029903 |
|---|---|
| Receipt number | R000034161 |
| Scientific Title | Multi-center study on prediction of response to cetuximab-based therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2017/11/09 |
| Last modified on | 2017/11/09 18:19:01 |
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Basic information
Public title
Multi-center study on prediction of response to cetuximab-based therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma
Acronym
Prediction of response to cetuximab-based therapy in patients with head and neck cancer
Scientific Title
Multi-center study on prediction of response to cetuximab-based therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma
Scientific Title:Acronym
Prediction of response to cetuximab-based therapy in patients with head and neck cancer
Region
| Japan |
Condition
Condition
Recurrent/metastasis head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We examine whether FCGR gene polymorphism and expression of AREG, EREG are useful as a biomarker of cetuximab (Cmab) combined chemotherapy for recurrent/metastatic head and neck cancer.
Basic objectives2
Others
Basic objectives -Others
We examine the possibility of estimating the effect of cetuximab only by blood specimens.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between FCGR gene polymorphism and expression of AREG, EREG and effect of cetuximab (Cmab) combination chemotherapy for recurrent/metastatic head and neck cancer
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Of the patients enrolled in "Randomized Phase II multicenter trial comparing modified PFE therapy and modified TPEx therapy for recurrent/metastatic head and neck squamous cell carcinoma" (UMIN 000025436), we agreed on this research document patient.
Key exclusion criteria
Patient who can not obtain consent for this study.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunao Kogashiwa |
Organization
Saitama Medical University International Medical Center
Division name
Department of Head and Neck Surgery, Otolaryngology
Zip code
Address
Yamane 1397-1, Hidaka, Saitama, Japan
TEL
042-984-4111
y_koga@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunao Kogashiwa |
Organization
Saitama Medical University International Medical Center
Division name
Department of Head and Neck Surgery, Otolaryngology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
042-984-4111
Homepage URL
y_koga@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 11 | Month | 09 | 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
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 11 | Month | 09 | Day |
Last modified on
| 2017 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034161
