UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015123 |
|---|---|
| Receipt number | 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 00:53:04 |
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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
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
jtaguchi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017592
