UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039971 |
|---|---|
| Receipt number | R000045573 |
| Scientific Title | Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2) |
| Date of disclosure of the study information | 2020/03/29 |
| Last modified on | 2024/10/01 12:55:20 |
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Basic information
Public title
Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2)
Acronym
Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2)
Scientific Title
Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2)
Scientific Title:Acronym
Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2)
Region
| Japan |
Condition
Condition
Advanced head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology | Radiology | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate for three cycles.
Key secondary outcomes
Tumor response assessment based on imaging findings and physical examinations, overall survival, progression-free survival, QOL score, adverse events, additional treatment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled for 3D-CRT or IMRT palliative fractionated radiotherapy (QUAD Shot; 14-14.8 Gy/4 fractions/2 days/cycle; 3-6 weeks interval; totally 3 cycles) for advanced head and neck squamous cell carcinoma (Stage III or IV on UICC 8th).
2) Patients who are not indicated for radical radiotherapy (conventionally fractionated irradiation with 60Gy or more). For example, patients who have refused radical radiotherapy or in whom radical radiotherapy is not feasible due to advanced lesions, old age, or complications. Patients who cannot tolerate conventionally fractionated irradiation under long-term hospitalization management due to complications such as delirium are also included in the criteria.
3) Patients aged 20 and older.
4) Patients pathologically diagnosed with squamous carcinoma of the head and neck region with lesions that can be assessed on imaging modalities.
5) Patients with ECOG performance status (PS) 0 to 3.
6) Patients who are fully informed prior to participating in this study, and voluntarily provide written informed consent.
Key exclusion criteria
1) Patients with previous radiotherapy on regions that overlap with the irradiated volume.
2) Women who are pregnant, breastfeeding or may be pregnant.
3) Patients whom the attending physician deems unsuitable for participation in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kodaira |
Organization
Aichi Cancer Center Hospital
Division name
Radiation Oncology
Zip code
464 8681
Address
1-1 Kanoko-den, Chikusa-ku, Nagoya, Aichi
TEL
+81527626111
109103@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Toya |
Organization
Nagasaki University
Division name
Radiological Sciences
Zip code
852 8501
Address
1-7-1, Sakamoto, Nagasaki
TEL
+81958197354
Homepage URL
toya@nagasaki-u.ac.jp
Sponsor or person
Institute
Japanese Radiation Oncology Study Group (JROSG)
Institute
Department
Personal name
Funding Source
Organization
Japanese Radiation Oncology Study Group (JROSG)
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
Aichi Cancer Center Hospital
Address
1-1 Kanoko-den, Chikusa-ku, Nagoya, Aichi
Tel
+81527626111
109103@aichi-cc.jp
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
愛知県がんセンター
熊本大学医学部
茨城県立中央病院
長崎大学病院
東京都立多摩総合医療センター
神奈川県立がんセンター
近畿大学医学部
東邦大学医療センター大森病院
国立がん研究センター東病院
岩手医科大学
三重大学医学部附属病院
愛知医科大学病院
朝日大学病院
名古屋市立大学大学院医学研究科
順天堂大学医学部付属順天堂医院
富山大学附属病院
北海道大学病院
兵庫県立がんセンター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
https://jrosg.jp
Publication of results
Unpublished
Result
URL related to results and publications
Analysis in progress
Number of participants that the trial has enrolled
50
Results
Analysis in progress
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients scheduled for QUAD shot with 3D-CRT or IMRT for advanced squamous cell carcinoma of the head and neck (UICC 8th edition stage III or IV).
Participant flow
The physician explains the clinical trial to the eligible patients and obtains their consent to participate in the trial.
Adverse events
Analysis in progress
Outcome measures
Percentage of QUAD shot 3 course completed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study type: A multicenter prospective observational study.
Primary outcome: Completion rate for three cycles.
Key secondary outcomes: Tumor response assessment based on imaging findings and physical examinations, overall survival, progression-free survival, QOL score, adverse events, additional treatment.
Management information
Registered date
| 2020 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045573
