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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009270
Receipt No. R000010890
Scientific Title Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-
Date of disclosure of the study information 2012/11/11
Last modified on 2016/03/14

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Basic information
Public title Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-
Acronym Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-
Scientific Title Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-
Scientific Title:Acronym Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the possibility of concurrent chemoradiotherapy with low-dose weekly docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Completion rate, safety
Key secondary outcomes Adverse event rate
treatment response rate
2-year overall survival rate
2-year disease specific survival rate
2-year disease free survival rate

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
Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 66Gy/33fractions/7weeks
Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) no tumor-specific pretreatment
2) no prior radiation against the same field as currently scheduled
3) estimable or measurable lesion
4) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5) expected survival duration for > 3months after the biginning of the treatment
6) no major impairment of liver, kidney, or bone marrow, fulfilling the condition of AST/ALT <2times the upper limit of normal, BUN <25mg/dl, serum creatinine <1.5mg/dl, creatinine clearance >=40ml/min(age 76-80 yeas old), 60ml/min >creatinine clearance >=40ml/min(age 20-75 yeas old), white blood cell count >4000/mm3, neutrophil count >2000/mm3, and platelet count >100,000/mm3
7) no evidence of active infection or fever >38C
8) written informed consent
Key exclusion criteria 1) interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT
2) major heart/lung disorders, or uncontrolled diabetes mellitus
3) distant metastases or second primary cancer except when there has been no evidence of the disease for more than 24 months without any treatment
4) major pulmonary effusion or ascites
5) neuropathy or edema
6) pregnancy or lactation
7) history of major allergy to medicine
8) long use of steroid
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hidenori Inohara
Organization Osaka University School of Medicine
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3951
Email hinohara@ent.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Norihiko Takemoto
Organization Osaka University School of Medicine
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3951
Homepage URL http://www.med.osaka-u.ac.jp/pub/ent/index.html
Email ntakemoto@ent.med.osaka-u.ac.jp

Sponsor
Institute Department of Otolaryngology-Head and Neck Surgery, Osaka University School of Medicine
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
2012 Year 11 Month 11 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 Open public recruiting
Date of protocol fixation
2012 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 11 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
2012 Year 11 Month 06 Day
Last modified on
2016 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010890

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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