UMIN-CTR Clinical Trial

Public title

Phase II trial of S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity

Acronym

S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity

Scientific Title

Phase II trial of S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity

Scientific Title:Acronym

S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity

Region

Japan

Condition

Advanced recurrent/metastatic carcinoma of the oral cavity

Classification by specialty

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose is to evaluate the efficacy and toxicity of S-1 plus Cetuximab combination chemotherapy for patients with advanced recurrent/metastatic carcinoma of the oral cavity who are inappropriate for platinum-based therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Overall survival

Key secondary outcomes

Progression Free Survival
Tumor response rate
Safety and adverse event

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 is administered intravenously once a week at a dose of 400mg/m2 for the first time and 250mg/m2 fir the second time or later. S-1 is administered orally twice a day at a dose of 40-60mg (80-120mg/day) for 28 days , followed by 14 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) Inoperable recurrent/metastatic carcinoma of the oral cavity.
2) Age >=20 at the time giving the consent.
3) Written informed consent with given enough explanation and full comprehension at his/her discretion.
4) ECOG performance status of PS 0-2.
5) Measurable lesion.
6) Inappropriate for platinum-based therapy or the refusal.
7) Adequate organ functions within 14 days at the time of registration:
1. WBC >=3,000 /mm3
2. Neutrophil >=1,500 /mm3
3. Platemet >=100,000 /mm3
4. Hemoglobin >=9.0 g/dL
5. T-bilirubin <=one-and-a half times of ULN.
6. AST, ALT <=two-and-a half times of ULN.
7. Creatinin clearance <=40ml/min.

Key exclusion criteria

1. History of hypersensitivity for the medicine of this study and the analogues.
2. receiving flucytocine.
3. possibly receiving flucytocine, HIV positive, or HBs antigen positive
4. Active infection requiring treatment.
5. Gastrointestinal disorder requiring treatment (paresis of intestine, ileus, etc).
6. Interstitial Pneumonia, pulmonary fibrosis
7. Uncontrolled diabetes mellitus.
8. Uncontrolled heart failure.
9. Severe liver failure.
10. Pregnant or lactating women or person in hope of the pregnancy of the partner.
11. Decision of ineligibility by a physician.

Target sample size

20

Name of lead principal investigator

1st name	Masaya
Middle name
Last name	Okura

Organization

Osaka University Graduate School of Dentistry

Division name

The First Department of Oral & Maxillofacial Surgery

Zip code

565-0871

Address

1-8 Yamanaoka Suita-city, Osaka

TEL

06-6879-2936

Email

okura@dent.osaka-u.ac.jp

Name of contact person

1st name	Masaya
Middle name
Last name	Okura

Organization

Society of Osaka Oral Cancer Researches

Division name

The First Department of Oral & Maxillofacial Surgery

Zip code

565-0871

Address

1-8 Yamanaoka Suita-city, Osaka

TEL

06-6879-2936

Homepage URL

Email

okura@dent.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Shinshu University Oral Surgery
Nagasaki University

Name of secondary funder(s)

Organization

Osaka University Dental Hospital

Address

1-8 Yamadaoka Suita Osaka

Tel

06-6879-5001

Email

okura@dent.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学歯学部附属病院

Date of disclosure of the study information

2016

Year

10

Month

12

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

Terminated

Date of protocol fixation

2016

Year

10

Month

07

Day

Date of IRB

2016

Year

10

Month

07

Day

Anticipated trial start date

2016

Year

10

Month

07

Day

Last follow-up date

2017

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

12

Day

Last modified on

2023

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028052