UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062684 |
|---|---|
| Receipt number | R000071771 |
| Scientific Title | A Multicenter Prospective Study to Evaluate the Efficacy and Safety of Weekly 8 Gy x 3 Palliative Radiotherapy for Symptomatic Head and Neck Cancer |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/25 18:00:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multicenter Prospective Study to Evaluate the Efficacy and Safety of Weekly 8 Gy x 3 Palliative Radiotherapy for Symptomatic Head and Neck Cancer
Acronym
Weekly 8 Study
Scientific Title
A Multicenter Prospective Study to Evaluate the Efficacy and Safety of Weekly 8 Gy x 3 Palliative Radiotherapy for Symptomatic Head and Neck Cancer
Scientific Title:Acronym
Weekly 8 Study
Region
| Japan |
Condition
Condition
Head and Neck Cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively evaluate the objective response to Weekly 8 (8 Gy once weekly for three fractions) in patients undergoing palliative radiotherapy for symptomatic head and neck cancer, and to assess its safety, symptom palliation, quality-of-life benefits, and treatment feasibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate of the target lesion at 2 months after Weekly 8 radiotherapy initiation
Key secondary outcomes
Objective response rate of the target lesion among patients with evaluable imaging at 2, 6, and 12 months after treatment, Incidence of treatment-related adverse events among patients who receive at least one fraction of the study treatment, Changes in QOL scores and proportion of patients with QOL improvement at 2, 6, and 12 months after treatment among patients who receive at least one fraction of the study treatment, Pain response rate at 2, 6, and 12 months after treatment among patients with pain who receive at least one fraction of the study treatment, Treatment completion rate, Treatment delay rate, Re-irradiation rate, Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Weekly 8 (8 Gy once weekly for three fractions)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The treating physician has determined prior to enrollment that the patient is not a candidate for local treatment with curative intent.
2. The patient has symptoms in the head and neck region caused by head and neck cancer.
3. The patient is aged 18 years or older at enrollment.
4. Written informed consent has been obtained from the patient.
5. The patient has an ECOG performance status of 0-3.
6. The patient has a pathological diagnosis of head and neck cancer.
7. The target lesion is adequately visualized on CT or MRI.
8. If the patient is receiving systemic therapy, the most recent systemic therapy must have been completed before the date of baseline imaging, and no systemic therapy may be administered within 7 days before the start of radiotherapy.
Key exclusion criteria
1. The patient is unable to maintain the supine position.
2. The patient has a history of radiotherapy overlapping the study treatment target lesion or the planned irradiation field.
3. The target lesion is a bone metastasis.
4. The patient is scheduled to initiate or resume systemic therapy after the baseline imaging assessment and before the 2-month imaging assessment, which is the primary endpoint assessment.
5. The patient is pregnant or may be pregnant.
6. The principal investigator or a subinvestigator considers the patient unsuitable for participation in the study.
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Makita |
Organization
National Cancer Center Hospital East
Division name
Department of Radiation Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
0471331111
kemaki3@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Fujisawa |
Organization
University of Tsukuba
Division name
Department of Radiation Oncology & Proton Medical Research Center, Faculty of Medicine
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Japan
TEL
0298533900
Homepage URL
takefujisawa33@gmail.com
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
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
National Cancer Center Hospital Institutional Review Board
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
0471331111
irst@ml.res.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071771
