UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021569 |
|---|---|
| Receipt number | R000024861 |
| Scientific Title | A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck |
| Date of disclosure of the study information | 2016/03/24 |
| Last modified on | 2023/12/26 11:15:49 |
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Basic information
Public title
A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck
Acronym
Carbon-Ion Therapy for Non-SCC of Head and Neck Tumor
Scientific Title
A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck
Scientific Title:Acronym
Carbon-Ion Therapy for Non-SCC of Head and Neck Tumor
Region
| Japan |
Condition
Condition
Non-squamous cell carcinoma of head and neck
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of carbon-ion radiotherapy for non-squamous cell carcinoma of head and neck, except for mucosal malignant melanoma and sarcoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Local control rate at 3 years
Key secondary outcomes
1) Overall survival, Disease-specific survival
2) Early and late adverse event rate
3) Local response rate (primary treatment outcome)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A total of 64.0 GyE of carbon-ion radiotherapy, consisting of 16 fractions of 4.0 GyE/ day for 6 to 8 times in 2 weeks
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A) Non-squamous cell carcinoma of head and neck which is pathologically or cytologically diagnosed, except for malignant melanoma and sarcoma
B) Patient without lymph node metastasis or with clinical stage of N1 which can be treated by the same irradiation field as primary lesion
C) Measurable primary lesion
D) No remote metastasis
E) 0 to 2 of performance status
F) 15 years or older and 80 years or younger of age, and 6 months or longer of expected survival
G) Patient is able to understand this clinical trial and is informed for the diagnosis and disease status. And patient can be given consent with document after explanation of this trial by study personnel
Key exclusion criteria
A) Past history of radiotherapy for the target lesion
B) Less than two weeks after the last administration of chemotherapy
C) Active double cancer
D) Active and intractable infection in the target lesion
E) Metal devices in the target lesion which is not able to be removed
F) Patient is not suitable for this study due to medical, psychological or the other reason
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Department of Carbon-ion Radiotherapy
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
hkatoh@kcch.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organizatio
Division name
Ion-beam Radiation Oncology Center
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
Homepage URL
hkatoh@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kanagawa Cancer Center IRB
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
045-520-2222
clinical_trials@kcch.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
神奈川県立がんセンター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 24 | 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
13
Results
This study confirmed safety and efficacy comparable to those reported from prior facilities.
Results date posted
| 2023 | Year | 12 | Month | 26 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024861
