UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002131 |
|---|---|
| Receipt number | R000002604 |
| Scientific Title | safety and efficacy of chemotherapy combined with radiotherapy for maxillary sinus carcinomas |
| Date of disclosure of the study information | 2009/06/29 |
| Last modified on | 2018/09/15 14:43:17 |
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Basic information
Public title
safety and efficacy of chemotherapy combined with radiotherapy for maxillary sinus carcinomas
Acronym
chemotherapy combined with radiotherapy for maxillary sinus carcinomas
Scientific Title
safety and efficacy of chemotherapy combined with radiotherapy for maxillary sinus carcinomas
Scientific Title:Acronym
chemotherapy combined with radiotherapy for maxillary sinus carcinomas
Region
| Japan |
Condition
Condition
maxxillary sinus carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of systemic and superselective intraarterial infusion chemotherapy combined with radiotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
systemic chemoterapy(two cycles,first and fifth week, 5 days ,5FU 800mg/mm3)
superselective intraarterial infusion chemotherapy(three cycles CDDP)
radiation therapy(50Gy)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) maxillary sinus carcinoma
2) enhanced CT
3) squamous cell carcinoma
4) performance status:0 or 1
5) WBC 3000/mm3 or more
Platelets 80000/mm3 or more
6) creatinine clearance 60ml/minute or more
Key exclusion criteria
1) distant metastasis
2) stenosis or sclerosis of carotid artery
3) 75 years old over
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Otsu |
Organization
Mie University Graduate School of Medicine
Division name
Department of Otorhinolaryngology-head and neck surgery
Zip code
Address
2-174,Edobashi,Tsu,Mie,514-8507 Japan
TEL
059-232-1111
otsu3mk@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Otsu |
Organization
Mie University Graduate School of Medicine
Division name
Department of Otorhinolaryngology-head and neck surgery
Zip code
Address
2-174,Edobashi,Tsu,Mie,514-8507 Japan
TEL
059-232-1111
Homepage URL
otsu3mk@nifty.com
Sponsor or person
Institute
Mie University Graduate School of Medicine,Department of Otorhinolaryngology-head and neck surgery
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine,Department of Otorhinolaryngology-head and neck surgery
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
| 2009 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002604
