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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013304
Receipt No. R000015088
Scientific Title Phase I study of concurrent chemoradiotherapy with docetaxel,cisplatin and 5-fluorouracil (DCF) in patients with locally advanced cancer of the external auditory canal and middle ear.
Date of disclosure of the study information 2014/03/01
Last modified on 2014/01/20

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Basic information
Public title Phase I study of concurrent chemoradiotherapy with docetaxel,cisplatin and 5-fluorouracil (DCF) in patients with locally advanced cancer of the external auditory canal and middle ear.
Acronym Phase I study of CCRT with DCF for advanced ear cancer
Scientific Title Phase I study of concurrent chemoradiotherapy with docetaxel,cisplatin and 5-fluorouracil (DCF) in patients with locally advanced cancer of the external auditory canal and middle ear.
Scientific Title:Acronym Phase I study of CCRT with DCF for advanced ear cancer
Region
Japan

Condition
Condition Neoplasm of the external auditory canal and middle ear
Classification by specialty
Hematology and clinical oncology Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the safety of concurrent chemoradiotherapy with docetaxel,cisplatin and 5-fluorouracil (DCF) in patients with locally advanced cancer of the external auditory canal and middle ear.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Maximum tolerated dose and recommended dose
Key secondary outcomes frequency and severity of side effects

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
Interventions/Control_1 Concurrent chemoradiotherapy
docetaxel 40-60 mg/m2/day day1 iv
cisplatin 70 mg/m2/day day1 iv
5-fluorouracil 700 mg/m2/day day1-5 civ
q4w , 2 cycle
RT 66Gy/33fr/7w
Radiotherapy starts on day1.
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 1) Histologically proven squamous cell carcinoma of the external auditory canal or middle ear
2) Primary lesion is located in the external auditory canal or middle ear
3) With T3 and T4 tumors in Pittsburgh tumor staging system (modified in 2000)
4) Patients with T3 tumors rejecting operation
5) No previous treatment of ear cancer without excisional biopsy or unresectable reccurrent tumor
6) No distant organ metastases
7) Aged 20 to 75 years old
8) ECOG PS of 0 or 1
9) No previous radiotherapy in head and neck lesion or radiologist permits curative additional radiotherapy
10) No previous chemotherapy within three years
11) Adequate organ functions
12) Written informed consent
Key exclusion criteria 1) Pregnant or lactating women or women of childbearing potential
2) Psychosis
3) Patients requiring systemic steroids medication
4) HBs antigen positive
5) HCV antibody positive
6) HIV antibody positive
7) Uncontrollable diabetes millutus
8) History of myocardial infarction within three months
9) History of unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema
10) Active bacterial or fungous infection
11) In case of judge as inadequate subjects by attending physician
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hasegawa, M.D, PhD
Organization Kobe University Hospital
Division name Otolaryngology-Head & Neck Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 JAPAN
TEL 0783825111
Email shingo@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hasegawa, M.D, PhD
Organization Kobe University Hospital
Division name Otolaryngology-Head & Neck Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 JAPAN
TEL 0783825111
Homepage URL
Email shingo@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
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 Preinitiation
Date of protocol fixation
2014 Year 02 Month 28 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 28 Day
Last modified on
2014 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015088

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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