UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of the efficacy and safety of 5-FU/CDDP/Cetuximab (FPE) induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
Acronym	Assessment of the efficacy and safety of FPE induction chemotherapy in patients with LASCCHN
Scientific Title	Assessment of the efficacy and safety of 5-FU/CDDP/Cetuximab (FPE) induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
Scientific Title:Acronym	Assessment of the efficacy and safety of FPE induction chemotherapy in patients with LASCCHN
Region	Japan

Condition
Condition	locally advanced head and neck squamous cell carcinoma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	efficacy and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	response rate of consecutive 3 courses
Key secondary outcomes	safety(CTCAE), progression free survival, compliance(dose intensity)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	5-FU 800mg/sqr day1-4 CDDP 80mg/sqr day1 Cetuximab 250mg/sqr(initial dose only:400mg/sqr)day1, 8, 15 every 21 days
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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with locally advanced head and neck squamous cell carcinoma(primary cite: larynx, oropharynx and hypopharynx. /N classification: N2, N2b, N2c and N3)
Key exclusion criteria	Performance status 2 and more
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Kuratomi
Organization	Saga University
Division name	Department of Otolaryngology - Head & Neck Surgery
Zip code	8498501
Address	5-1-1, Nabeshima, Saga-city
TEL	0952-34-2379
Email	kuratomy@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Moriyasu Middle name Last name Yamauchi
Organization	Saga University
Division name	Department of Otolaryngology - Head & Neck Surgery
Zip code	8498501
Address	5-1-1 Nabeshima, Saga-city
TEL	0952-34-2379
Homepage URL
Email	yamamori@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

Funding Source
Organization	Saga University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saga University
Address	5-1-1 Nabeshima
Tel	0952-34-3400
Email	none

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	2018 Year 02 Month 05 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	Terminated
Date of protocol fixation	2018 Year 02 Month 05 Day
Date of IRB	2018 Year 02 Month 05 Day
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date	2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 05 Day
Last modified on	2022 Year 08 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035515