UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016047 |
|---|---|
| Receipt number | R000018650 |
| Scientific Title | Study of superselective intra-arterial chemotherapy using docetaxel and cisplatin and radiotherapy for advanced oral cancer |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2015/01/09 17:38:48 |
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Basic information
Public title
Study of superselective intra-arterial chemotherapy using docetaxel and cisplatin and radiotherapy for advanced oral cancer
Acronym
Study of superselective intra-arterial chemoradiotherapy for advanced oral cancer
Scientific Title
Study of superselective intra-arterial chemotherapy using docetaxel and cisplatin and radiotherapy for advanced oral cancer
Scientific Title:Acronym
Study of superselective intra-arterial chemoradiotherapy for advanced oral cancer
Region
| Japan |
Condition
Condition
advances oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is to evaluate the therapeutic results and toxicities in patients with advanced oral cancer treated with superselective intra-arterial chemoradiotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
survival rate
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Catheterization from the superficial temporal and occipital arteries is inserted into the target artery. Treatment consisted of intra-arterial chemotherapy (docetaxel, total 60 mg/m2, cisplatin, total 150 mg/m2) and daily concurrent radiotherapy (total of 60 Gy) for 6 weeks between December 2014 and November 2019.
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
Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, a white blood cell count of at least 3500 cells/mm3, a platelet count of at least 100,000/mm3, and a hemoglobin level of
at least 9 g/dL.
Key exclusion criteria
Patients with performance status 3, 4, cerebral infarction, or severe dysfunction of the liver, kidney, heart, or lung were ineligible.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Mitsudo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2800
mitsudo@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Mitsudo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Oral and Maxillofacial
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2800
Homepage URL
mitsudo@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
| 2015 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | 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
| 2014 | Year | 12 | Month | 24 | Day |
Last modified on
| 2015 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018650
