UMIN-CTR Clinical Trial

Public title

Cetuximab in combination with S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer

Acronym

C-mab+S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer

Scientific Title

Cetuximab in combination with S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer

Scientific Title:Acronym

C-mab+S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer

Region

Japan

Condition

Head and Neck cancer

Classification by specialty

Medicine in general	Hematology and clinical oncology	Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to determine if the combination of cetuximab and S-1 can increase the effectiveness of treatment for head and neck cancer. Cetuximab has recently been approved for head and neck cancer when used in combination with radiation or conventional chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

the objective response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Key secondary outcomes

Overall Survival
Progression-Free Survival
Safety
Patients' Quality of life

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cetuximab:400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY. Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations.
S-1:A fixed dose of 80,100 or 120 mg/patient p.o. bid for 14 days, followed by 7 days rest.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically confirmed carcinoma of the head and neck
2)20 Years and older
3)written informed consent
4)ECOG performance status (PS) 0-2
5)Absolute neutrophil count >= 1,500/mm3
6)Platelet count >= 100,000/mm3
7)Hemoglobin >=9.0 g/dL (without transfusions)
8)Bilirubin <=1.5 times upper limit of normal(ULM)
9)AST and ALT <= 5 times upper limit of normal (ULN)
10)Creatinine normal OR creatinine clearance >=50 mL/min

Key exclusion criteria

1)Known hypersensitivity to S-1, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs
2)Being treated with other pyrimidine fluoride antineoplastic agents, flucytosine or therapeutic anticoagulation (prophylactic use of warfarin 1 mg per day is allowed)
3)Known Human Immunodeficiency Virus (HIV) infection, active or chronic carrier of hepatitis B virus (HBV) (HBV antigen positive or HBV deoxyribonucleic acid (DNA) positive) or hepatitis C virus (HCV) (HCV antibody positive)
4)Current severe infection, or suspicious of severe infection
5)Significant comorbid disease such as paresis of intestine and ileus.
6)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT
7)Uncontrolled diabetes mellitus
8)Severe heart disease or liver disease
9)Pregnant women are excluded from this study because cetuximab has the potential for teratogenic or abortifacient effects. Women of child-bearing potential and men are also exluded.
10)Inappropriate patients for this study judged by the attending physician

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Junkichi Yokoyama

Organization

Juntendo university faculty of medicine

Division name

Department of Otorhinolaryngology, head and neck surgery

Zip code

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name	Junkichi Yokoyama

Organization

Juntendo university faculty of medicine

Division name

Department of Otorhinolaryngology, head and neck surgery

Zip code

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

Homepage URL

Email

Institute

Juntendo university faculty of medicine

Institute

Department

Personal name

Organization

Health and Labor Science Reserch Grant for Clinical Cancer Reserch

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学医学部附属順天堂医院
JUNTENDO UNIVERSITY HOSPITAL

Date of disclosure of the study information

2013

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

03

Month

22

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

23

Day

Last modified on

2016

Year

10

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012065