UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of S-1 plus Cetuximab combination therapy in patients inappropriate for platinum-based therapy with recurrent/metastatic squamous cell carcinoma of the head and neck
Acronym	S-1 plus Cetuximab combination therapy in patients inappropriate for platinum-based therapy with recurrent/metastatic squamous cell carcinoma of the head and neck
Scientific Title	Phase II trial of S-1 plus Cetuximab combination therapy in patients inappropriate for platinum-based therapy with recurrent/metastatic squamous cell carcinoma of the head and neck
Scientific Title:Acronym	S-1 plus Cetuximab combination therapy in patients inappropriate for platinum-based therapy with recurrent/metastatic squamous cell carcinoma of the head and neck
Region	Japan

Condition
Condition	Recurrent/metastatic squamous cell carcinoma of the head and neck
Classification by specialty	Medicine in general Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and toxicity of S-1 plus Cetuximab combination therapy as a first line treatment in patients inappropriate for platinum-based therapy with recurrent/metastatic squamous cell carcinoma of the head and neck
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	disease control rate, progression free survival, overall survival, time to treatment failure, dose intensity, safety

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	S-1 is administered orally twice a day at a dose of 40-60 mg (80-120 mg/day) for 14 days, followed by 7 days rest. Cetuximab is administered intravenously once a week at a dose of 400mg/m2 for the first time and 250mg/m2 for the second time or later.
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	(1)Inoperable recurrent/metastatic head and neck cancer (2)Inappropriate for definitive radiotherapy (3)Histologically or cytologically proven squamous cell carcinoma (4)Age >=20 at the time of registration (5)ECOG performance status 0-2 (6)Inappropriate for platinum-based thrapy for any of the following reasons: Age >=20, <70 and PS 2 Age >=70, <75 and PS 1-2 Age >=75 and PS 0-2 Complications Refusal of platinum-based therapy (7)Measurable lesion (8)No prior chemotherapy after diagnosis of recurrence or metastasis, excluding immune checkpoint inbibitor (9)Adequate organ functions: Neutrophil >=1,500 /mm3 Platelet >=100,000 /mm3 Hemoglobin concentration >=8.0 g/dl AST or ALT <=100 U/L (<=200 U/L case with liver metastasis) T-bilirubin <=1.5 mg/dl Creatinin clearance >=40 ml/min (10)Life expectancy of more than 3 months (11)Written informed consent
Key exclusion criteria	(1)History of severe hypersensitivity (2)Active infection (3)Severe and uncontrolled complication(severe heart failure, cerebrovascular disease, pulmonary fibrosis, renal failure, liver failure, active peptic ulcer, uncontrolled diabetes mellitus, uncontrolled hypertention, etc.) (4)Uncontrolled pleural, pericardial effusion or ascites (5)Symptomatic brain metastasis (6)Simultaneous or metachronous double cancers within the past 5 years other than skin cancer (malignant melanoma is excluded), carcinoma in situ of uterine cervix and mucosal carcinoma of digestive tract (7)Receiving flucytocine (8)HBs Ag positive (9)Pregnant or lactating women or women of childbearing potential and men in hope of the pregnancy of the partner (10)Unstable psychiatric disease (11)Surgery or radiotherapy within 4 weeks (12)Decision of ineligibility by a physician
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Shimizu
Organization	Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name	Department of medical oncology
Zip code	060-8638
Address	North 15, West 7, Kita-ku, Sapporo
TEL	011-706-5551
Email	y-simz@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Taguchi
Organization	Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name	Department of medical oncology
Zip code	060-8638
Address	North 15, West 7, Kita-ku, Sapporo
TEL	011-706-5551
Homepage URL
Email	jtaguchi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
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	Hokkaido University Hospital Division of Clinical Research Administration
Address	North 15, West 7, Kita-ku, Sapporo
Tel	011-706-7636
Email	crjimu@huhp.hokudai.ac.jp

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	北海道大学病院（北海道）、札幌医科大学附属病院（北海道）、旭川医科大学病院（北海道）、北海道がんセンター（北海道）、手稲渓仁会病院（北海道）、市立札幌病院（北海道）、恵佑会札幌病院（北海道）、KKR札幌医療センター（北海道）、帯広厚生病院（北海道）、弘前大学医学部附属病院（青森県）

Other administrative information
Date of disclosure of the study information	2014 Year 09 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	21
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	2014 Year 08 Month 15 Day
Date of IRB	2014 Year 08 Month 07 Day
Anticipated trial start date	2014 Year 09 Month 16 Day
Last follow-up date	2019 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	2014 Year 09 Month 11 Day
Last modified on	2019 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017592