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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013170
Receipt No. 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

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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
Email 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
Email hinohara@ent.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Otorhinolaryngolory-Head and Neck Surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015357

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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