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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024686
Receipt No. R000028402
Scientific Title Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck
Date of disclosure of the study information 2016/11/02
Last modified on 2016/11/02

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Basic information
Public title Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck
Acronym TPF study for Japanese
Scientific Title Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck
Scientific Title:Acronym TPF study for Japanese
Region
Japan

Condition
Condition Locally advanced head and neck cancer
Classification by specialty
Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the feasibility of TPF as induction chemotherapy for Japanese head and neck cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Feasibility of TPF
Key secondary outcomes overall response rate to TPF
local recurrence-free survival
progression-free survival
overall survival
safety profile

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction chemotherapy(TPF)
Docetaxel: 70-75mg/m2, day1
Cisplatin: 70-75mg/m2, day1
Fluorouracil: 750mg/m2, day1-5
q3w, total 3cycles

Chemoradiotherapy(CRT)
Cisplatin: 20mg/m2, day1-4
q3w, total 3cycles
Radiation: 70Gy
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 Histologically confirmed Squamous cell carcinoma
Following primary sites: Larynx, Oropharynx and Hypopharynx
Unresectable locally advanced head and neck cancer
No metastasis
Age from 20 to 75
PS(ECOG): 0 or 1
No prior treatment of definitive operation
No prior treatment with systemic anti-cancer therapy, radiotherapy or hormone therapy
Adequate organ function
Signed informed consent
Key exclusion criteria Active bacterial or fungus infection
Active Malignant disease, other than that being treated in this study
Pregnant or lactating women
Clinically significant and/or uncontrolled heart disease
History of cerebrovascular disease
Uncontrolled diabetes or hypertension
Severe complications
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Tahara
Organization National Cancer Center Hospital East
Division name Head and Neck Medical Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email matahara@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Okano
Organization National Cancer Center Hospital East
Division name Head and Neck Medical Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email sokano@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center Hospital East
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hyogo Cancer Center Hospital
Jikei University School of Medicine Hospital
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
2016 Year 11 Month 02 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 Completed
Date of protocol fixation
2009 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2014 Year 01 Month 07 Day
Date of closure to data entry
2015 Year 02 Month 03 Day
Date trial data considered complete
2015 Year 02 Month 03 Day
Date analysis concluded
2016 Year 09 Month 09 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 02 Day
Last modified on
2016 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028402

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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