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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020218
Receipt No. R000023349
Scientific Title Study on safety and efficacy of cetuximab in locally advanced, recurrent and/or metastatic oral cancer
Date of disclosure of the study information 2015/12/16
Last modified on 2015/12/22

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Basic information
Public title Study on safety and efficacy of cetuximab in locally advanced, recurrent and/or metastatic oral cancer
Acronym Safety and efficacy of cetuximab in oral cancer
Scientific Title Study on safety and efficacy of cetuximab in locally advanced, recurrent and/or metastatic oral cancer
Scientific Title:Acronym Safety and efficacy of cetuximab in oral cancer
Region
Japan

Condition
Condition Oral cancer
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the usage and safety and efficacy of cetuximab for oral cancer patients, and to contribute to the proper use.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events, 1-year progression-free survival and 1-year survival rate.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The subjects must meet all the following criteria.
1. Malignant tumors originated from the oral cavity.
2. Confirmed that a histopathological malignant.
3. In locally advanced cases, the cases in UICC 7th edition stage III / IV, or recurrent and/or metastatic cases with not indicated for local therapy.
4. Received any of the therapies described below.
i) Radiation therapy (at least 60Gy)
ii) Some chemotherapy
5. Age at the time of registration at least 20 years of age
6. Performance status: 0-2
7. December 21, 2012 or later, the case that the treatment of cetuximab has been started.
Key exclusion criteria Patients also applicable in one of the following are excluded as a target.
1. Cases with cetuximab treatment to December 20, 2012 or earlier.
2. Cases with complications in life prognosis in addition to oral cancer.
3. Cases with active double cancer. However, gastric cancer was cured by carcinoma in situ, or endoscopic mucosal resection that is judged to be cured with local treatment, esophageal cancer, colorectal cancer, such as pM it is not included in the activities of the overlapping cancer.
4. Other, patients principal investigator has determined to be inappropriate as a subject.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Souichi Yanamoto
Organization Nagasaki University
Division name Hospital, Dentistry for Medically Compromised Patient
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7698
Email syana@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Souichi Yanamoto
Organization Nagasaki University
Division name Hospital, Dentistry for Medically Compromised Patient
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7698
Homepage URL
Email syana@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 16 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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case contro study on rare disease.
In later ethics committee approval until March 2016 to the jaw bone osteomyelitis patients who visited the facility,
survey of the following items.
1. Age
2. Gender
3. BMI
4. Smoking status
5. Drinking situation
6. PS (ECOG)
7. complications
8. medical history
9. allergy
10. primary site
11. histological type
12. TNM classification (UICC 7th edition)
13. case classification (locally advanced oral cancer or recurrent and/or metastatic oral cancer)
14. treatment history (surgery, radiation therapy, chemotherapy)
15. clinical examination value (up to the start of administration two weeks ago)
16. Description excimer blanking contents of the regimen (combination drug, dose, dosing interval, radiation dose, administration start date, end date of administration, administration end reason)
17. Treatment line (1st line, 2nd line, etc.)
18. cetuximab administration as a post-treatment (dose, dosing interval, the administration period)
19. effect judgment (target lesion effect judgment, non-target lesions effect judgment, new lesions, total effect)
20. outcome (outcome, the final progression-free date confirmed)
21. adverse events (adverse event name, date expression, CTCAE Grade, outcome-outcome date, and treatment related to events, causal relationship)

Management information
Registered date
2015 Year 12 Month 16 Day
Last modified on
2015 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023349

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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