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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021569
Receipt No. R000024861
Official scientific title of the study 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 2016/12/19

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Basic information
Official scientific title of the study A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck
Title of the study (Brief title) 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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Dr. Takuma Nomiya
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Ion-beam Radiation Oncology Center
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Email tnomiya@kcch.jp

Public contact
Name of contact person Dr. Takuma Nomiya
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organizatio
Division name Ion-beam Radiation Oncology Center
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Homepage URL
Email tnomiya@kcch.jp

Sponsor
Institute Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 03 Month 16 Day
Anticipated trial start date
2016 Year 03 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 03 Month 22 Day
Last modified on
2016 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024861


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