UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013170 |
|---|---|
| Receipt number | R000015357 |
| Scientific Title | Phase I trial of Docetaxel+Cisplatin+Cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2016/03/10 16:11:09 |
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Basic information
Public title
Phase I trial of Docetaxel+Cisplatin+Cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinoma
Acronym
Phase I trial of Docetaxel+Cisplatin+Cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinoma
Scientific Title
Phase I trial of Docetaxel+Cisplatin+Cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinoma
Scientific Title:Acronym
Phase I trial of Docetaxel+Cisplatin+Cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinoma
Region
| Japan |
Condition
Condition
head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and feasibility of docetaxel/cisplatin/cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinoma patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
completion rate of treatment
Key secondary outcomes
response rate, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
docetaxel, cisplatin, cetuximab
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 recurrent or metastatic head and neck cancer with histologically diagnosed as squamous cell carcinoma
2) Measurable disease
3) ECOG PS 0 or 1
4) Age is 20 years or older
5) Adequate organ function
6) Life expectancy of at least 3 months
7) Women of child-bearing potential and men who are able to father a child agree with using adequate contraception
8) Written informed consent to the study signed by the patient
Key exclusion criteria
1) Past history of chemotherapy within 3 months
2) Past history of surgery or radiotherapy within 4 weeks
3) Double cancer within 2 years
4) Brain metastasis with active symptoms
5) Severe myelosuppressive or infectious status
6) Pulmonary fibrosis, acute lung injury, interstitial pneumonia
7) Other severe disease such as heart failure, kidney failure
8) Past history of allergy against docetaxel, cisplatin or cetuximab
9) Pregnant or nursing women
10) In the middle of other chemotherapy
11) Past history of cetuximab
12) Other significant disease that in the investigator's opinion would exclude the subject from the trial
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Inohara |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngolory-Head and Neck Surgery
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3951
hinohara@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Inohara |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngolory-Head and Neck Surgery
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3951
Homepage URL
hinohara@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Otorhinolaryngolory-Head and Neck Surgery
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
| 2014 | Year | 02 | Month | 15 | Day |
Last modified on
| 2016 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015357
| 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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| Registered date | File name |
