UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013504 |
|---|---|
| Receipt number | R000015778 |
| Scientific Title | Tightening of indication assessments of post-operative radiotherapy for heas and neck carcinoma patients |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2019/09/30 09:39:03 |
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Basic information
Public title
Tightening of indication assessments of post-operative radiotherapy for heas and neck carcinoma patients
Acronym
Assessment of post-operative radiotherapy for head and neck carcinoma patients
Scientific Title
Tightening of indication assessments of post-operative radiotherapy for heas and neck carcinoma patients
Scientific Title:Acronym
Assessment of post-operative radiotherapy for head and neck carcinoma patients
Region
| Japan |
Condition
Condition
Oropharyngeal carcinoma, Hypopharyngeal carcinoma, Laryngeal carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The assessment of the possibility to minimaize the indication for post-operative radiotherapy in head and neck carcinoma patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The assessment of the possibility for post-operative radiotherapy in head and neck carcinoma patients as the following two criterias; 1, positive margin at the primary site; 2, extra capsular invasion in the cervical metastatic lymph node.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Surgical margin negative in the primary site and extra-capsular invasion negative in the metastatic lymph node (non-post-oerative radiotherapy group)
Interventions/Control_2
Surgical margin positive in the primary site and/or extra-capsular invasion positeve in the metastatic lymph node (post-operative radiotherapy group)
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
Oropharyngeal carcinoma, hypopharyngeal carcinoma and laryngeal carcinoma patients who will be resected the primary site by minimum invasion surgery with or without neck dissection.
Key exclusion criteria
Refused cases for surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Oridate |
Organization
Yokohama City University School of Medicine
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2685
noridate@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goshi Nishimura |
Organization
Yokohama City University School of Medicine
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2687
Homepage URL
gnishimu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University School of Medicine, Department of Otorhinolaryngology, Head and Neck SUrgery
Organization
Division
Category of Funding Organization
Self funding
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | 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
| 2014 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2014 | Year | 03 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015778
