UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049781 |
|---|---|
| Receipt number | R000037569 |
| Scientific Title | Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2022/12/15 |
| Last modified on | 2022/12/14 14:21:58 |
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Basic information
Public title
Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma
Acronym
Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma
Scientific Title
Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma
Scientific Title:Acronym
Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma
Region
| Japan |
Condition
Condition
head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to validate efficacy and safety of an algorithm which assign consequent modality based on therapeutic response of each case.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival
Key secondary outcomes
laryngeal preservation rate
swallowing function
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically or Cytological proven squamous cell carcinoma of the head and neck
Primary lesion located at oropharynx, hypopharynx, or larynx
ECOG performance status 0 to2
No history of irradiation to head and neck
Adequate organ function including;
WBC>=3,500/mm3
platlet>=100,000
Creatinin clearance>=30 (Cockcroft-Gault formula)
Written informed consent
Women of child-bearing potential and men who are able to father a child agree with using adequate contraception
Key exclusion criteria
Patients who reject chemoradiotherapy or bioradiotherapy as initial therapeutic intervention
T4a cases with extensive distruction of laryngeal framework and in-operable T4b cases
Distant metastasis cases
Sever heart disease or heart failure
Myocardial infarction or angina attack within 6 month
Cases with Synchronous multiple primary cancer other than esophageal cancer which can be treated by Endoscopic Submucosal Dissection or endoscopic mucosal resection
Other significant disease that in the investigator's opinion would exclude the subject from the trial.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Muneyuki |
| Middle name | |
| Last name | Masuda |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Head and Neck Surgery
Zip code
811-1395
Address
3-1-1 Notame, Minami-ku, Fukuoka
TEL
0925413231
sttoshny@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Toh |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Head and Neck Surgery
Zip code
811-1395
Address
3-1-1 Notame, Minami-ku, Fukuoka
TEL
0925413231
Homepage URL
sttoshny@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyushu Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center
Address
3-1-1 Notame, Minami-ku, Fukuoka
Tel
0925413231
sttoshny@gmail.com
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
独立行政法人国立病院機構九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
trial on going
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
