UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042226
Receipt No. R000048210
Scientific Title Prospective observational study of the efficacy and safety of carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck
Date of disclosure of the study information 2020/10/26
Last modified on 2020/10/24

* 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 Carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck
Acronym iROCK-2001HN
Scientific Title Prospective observational study of the efficacy and safety of carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck
Scientific Title:Acronym iROCK-2001HN
Region
Japan

Condition
Condition mucosal malignant melanoma of the head and neck
Classification by specialty
Oto-rhino-laryngology Radiology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of carbon-ion radiotherapy followed by Nivolumab for primary 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 One-year progression-free survival after Nivolumab
Key secondary outcomes

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)Histologically or cytologically confirmed mucosal malignant melanoma of the head and neck
2)Patients where radical carbon-ion radiotherapy is possible
3)Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
4)Patients aged 20 years or older at the time of consent
5)Measurable disease, according to RECIST version 1.1
6)Life expectancy of greater than 12 weeks in the opinion of the investigator
7)Ability to understand and the willingness to sign written informed consent documents
Key exclusion criteria 1)Patients with interstitial pneumonia, drug-induced interstitial lung disease or clinically active interstitial lung disease on chest CT scan
2)Patients with autoimmune disorders
3)Known allergy to compounds of similar chemical or biologic composition to Nivolumab
4)Pregnant or lactating females
5)Patients in which the physician decides that participation in the study is unsuitable
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Nobutaka
Middle name
Last name Mizoguchi
Organization Kanagawa Cancer Center,
Kanagawa Prefectural Hospital Organization
Division name Department of Radiation Oncology
Zip code 241-8515
Address 2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa prefecture, JAPAN
TEL 045-520-2222
Email mizoguchin@kcch.jp

Public contact
Name of contact person
1st name Nobutaka
Middle name
Last name Mizoguchi
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Department of Radiation Oncology
Zip code 241-8515
Address 2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa prefecture, JAPAN
TEL 045-520-2222
Homepage URL
Email mizoguchin@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 Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization KCCH support center for the development of new therapies
Address 2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa prefecture, JAPAN
Tel 045-520-2222
Email chiken-jimu4@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

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 26 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
2020 Year 10 Month 12 Day
Anticipated trial start date
2020 Year 10 Month 19 Day
Last follow-up date
2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:
-single-center prospective observational study
Research agenda:
-Prospective observational study of the efficacy and safety of carbon ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck
Eligibility:
-Patients with malignant mucosal melanoma of the head and neck
-Patients who will be seen at our facility between October 2020 and September 2023, meet the selection criteria, and consent to this study
Primary endpoint:
-One-year progression-free survival after Nivolumab

Management information
Registered date
2020 Year 10 Month 24 Day
Last modified on
2020 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.