UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015123
Receipt No. R000017592
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
Date of disclosure of the study information 2014/09/11
Last modified on 2019/10/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000017592

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.