UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055558 |
|---|---|
| Receipt number | R000063488 |
| Scientific Title | A prospective observational study to investigate the efficacy of palliative hypofractionated radiotherapy (QUAD shot) for advanced head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/20 11:00:31 |
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Basic information
Public title
A prospective observational study to investigate the efficacy of palliative hypofractionated radiotherapy (QUAD shot) for advanced head and neck squamous cell carcinoma
Acronym
A prospective observational study to investigate the efficacy of palliative hypofractionated radiotherapy (QUAD shot) for advanced head and neck squamous cell carcinoma
Scientific Title
A prospective observational study to investigate the efficacy of palliative hypofractionated radiotherapy (QUAD shot) for advanced head and neck squamous cell carcinoma
Scientific Title:Acronym
A prospective observational study to investigate the efficacy of palliative hypofractionated radiotherapy (QUAD shot) for advanced head and neck squamous cell carcinoma
Region
| Japan |
Condition
Condition
head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of palliative hypofractionated radiotherapy (QUAD shot) for advanced head and neck squamous cell carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
3. Tumor shrinkage on imaging, tumor shrinkage on physical findings, overall survival, progression-free survival, QOL score, and adverse events one month after the end of the course.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with advanced head and neck squamous cell carcinoma (UICC 8th edition stage III or IV) scheduled for palliative hypofractionated radiotherapy using 3D-CRT or IMRT (QUAD Shot; 14-14.8 Gy/4 fractions/2 days/course, with a rest period of 3-6 weeks, total of 3 courses).
Key exclusion criteria
Patients who refused radiation therapy
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Tanaka |
Organization
Asahi University Hospital
Division name
Dept. of Radiation Oncology
Zip code
5011151
Address
3-23 Hashimoto-cho, Gifu city
TEL
09076730893
c.bluered@gmail.com
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Tanaka |
Organization
Asahi Univ. Hospital
Division name
Radiation Oncology
Zip code
500-8523
Address
3-23Hashimoto cho
TEL
058-253-8001
Homepage URL
c.bluered@gmail.com
Sponsor or person
Institute
Asahi University
Institute
Department
Personal name
Osamu Tanaka
Funding Source
Organization
none
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
Asahi University Hospital
Address
3-23 Hashimoto cho, Gifu city
Tel
0582538001
c.bluered@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063488
