UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024371 |
|---|---|
| Receipt number | 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 | 2023/04/18 12:29:08 |
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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 | 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
okura@dent.osaka-u.ac.jp
Public contact
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
okura@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka 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
Shinshu University Oral Surgery
Nagasaki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Dental Hospital
Address
1-8 Yamadaoka Suita Osaka
Tel
06-6879-5001
okura@dent.osaka-u.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
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
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
Other related information
Management 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
