UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042226
Receipt number 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 00:32:37

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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 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


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

Value
https://center6.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