UMIN-CTR Clinical Trial

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

mucosal malignant melanoma of the head and neck

Classification by specialty

Oto-rhino-laryngology	Radiology	Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

One-year progression-free survival after Nivolumab

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Institute

Department

Personal name

Organization

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

10

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

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