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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023182
Receipt No. R000026725
Official scientific title of the study A phase II study of carbon-ion radiotherapy combined with anti-tumor agents for mucosal malignant melanoma of the head and neck
Date of disclosure of the study information 2016/08/01
Last modified on 2017/06/05

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Basic information
Official scientific title of the study A phase II study of carbon-ion radiotherapy combined with anti-tumor agents for mucosal malignant melanoma of the head and neck
Title of the study (Brief title) Carbon-ion therapy for malignant melanoma of the head and neck (iROCK-1603HN)
Region
Japan

Condition
Condition mucosal malignant melanoma of the 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 mucosal malignant melanoma of the head and neck.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year survival rate
Key secondary outcomes 1) Local control rate
2) Disease-specific survival
3) Early and late adverse event rate
4) Local response rate

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 1) Mucosal malignant melanoma of head and neck which is pathologically or cytologically diagnosed
2) Patient without lymph node metastasis (N0) and no remote metastasis(M0)
3) Measurable primary lesion
4) 0 to 2 of performance status
5) 15 years or older and 80 years or younger of age
6)Sufficient organ functions
7) 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 1)Patient with past history of radiotherapy for the targeted lesion
2)Patient is within 2 weeks after the final chemoterapy
3)Patient with active double cancer

4)Patients with active and intractable infection in the targeted lesion
5) Patient with metal devices in the lesion
6) Other medical or psychological condition which is unsuitable for carbon-ion therapy
Target sample size 65

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 Organization
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

Funding Source
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

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 08 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 03 Month 09 Day
Anticipated trial start date
2016 Year 08 Month 01 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 07 Month 15 Day
Last modified on
2017 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026725

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
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