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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024371
Receipt No. R000028052
Scientific Title Phase II trial of S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity
Date of disclosure of the study information 2016/10/12
Last modified on 2017/01/23

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Basic information
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
Condition Advanced recurrent/metastatic carcinoma of the oral cavity
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression Free Survival
Tumor response rate
Safety and adverse event

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 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

Eligibility
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

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaya Okura
Organization Osaka University Graduate School of Dentistry
Division name The First Department of Oral & Maxillofacial Surgery
Zip code
Address 1-8 Yamanaoka Suita-city, Osaka
TEL 06-6879-2936
Email okura@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Okura
Organization Society of Osaka Oral Cancer Researches
Division name The First Department of Oral & Maxillofacial Surgery
Zip code
Address 1-8 Yamanaoka Suita-city, Osaka
TEL 06-6879-2936
Homepage URL
Email okura@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Shinshu University Oral Surgery
Nagasaki University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 12 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
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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 12 Day
Last modified on
2017 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028052

Research Plan
Registered date File name
2017/04/13 S1CEt研究計画書33FV.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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