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

* 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 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

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

Value
https://center6.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