UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Makoto Tahara
Organization	National Cancer Center Hospital East
Division name	Head and Neck Medical Oncology
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Email	matahara@east.ncc.go.jp

Public contact
Name of contact person	Susumu Okano
Organization	National Cancer Center Hospital East
Division name	Head and Neck Medical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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