UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013304 |
|---|---|
| Receipt number | 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 22:25:03 |
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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
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
shingo@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015088
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| Registered date | File name |
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| Registered date | File name |
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