UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029351 |
|---|---|
| Receipt number | R000033543 |
| Scientific Title | Multicenter retrospective study of efficacy of the combination of cetuximab and paclitaxel in patients with recurrent and/or metastatic oral squamous cell carcinoma |
| Date of disclosure of the study information | 2017/09/29 |
| Last modified on | 2017/09/29 14:36:39 |
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Basic information
Public title
Multicenter retrospective study of efficacy of the combination of cetuximab and paclitaxel in patients with recurrent and/or metastatic oral squamous cell carcinoma
Acronym
Retrospective study of the efficacy of the combination of cetuximab and paclitaxel
Scientific Title
Multicenter retrospective study of efficacy of the combination of cetuximab and paclitaxel in patients with recurrent and/or metastatic oral squamous cell carcinoma
Scientific Title:Acronym
Retrospective study of the efficacy of the combination of cetuximab and paclitaxel
Region
| Japan |
Condition
Condition
Recurrent and/or metastatic oral squamous cell carcinoma
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigated the efficacy and safety of the combination of Cetuximab+ Paclitaxel therapy for recurrent / metastatic oral cavity cancer, and will clarify the usefulness of the treatment strategy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Response rate of the combination of Cetuximab+ Paclitaxel therapy from the treatment start
Key secondary outcomes
One year progression free survival and overall survival
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
1. The oral cavity is a primary site, and radical surgery is performed on the primary tumor.
2. It has been confirmed pathologically that it is squamous cell carcinoma.
3. Cet + PTX therapy is in effect as a target lesion of recurrence / metastatic lesion.
4. At least 1 year has elapsed regardless of the presence or absence of an event from the start of administration.
5. Age is over 20 years old.
Key exclusion criteria
1. Before December 2012 there is a treatment history with Cetuximab.
2. Besides oral cancer, it has serious complications affecting life prognosis
3. Other patients whose research managers judged inappropriate as subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomofumi Naruse |
Organization
Nagasaki university
Division name
Department of clinical oral oncology
Zip code
Address
1-7-1, sakamoto, Nagasaki, Japan
TEL
095-819-7698
naruse12@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomofumi Naruse |
Organization
Nagasaki university
Division name
Department of clinical oral oncology
Zip code
Address
1-7-1, sakamoto, Nagasaki, Japan
TEL
095-819-7698
Homepage URL
naruse12@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 09 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2017 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033543
