UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031324 |
|---|---|
| Receipt number | R000035754 |
| Scientific Title | Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy |
| Date of disclosure of the study information | 2018/02/19 |
| Last modified on | 2022/08/20 09:43:12 |
* 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
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Acronym
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Scientific Title
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Scientific Title:Acronym
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Region
| Japan |
Condition
Condition
Head and Neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect of treatment, who received nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
1) Progression Free Survival
2) Quality of Life score
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
| Medicine |
Interventions/Control_1
Intravenous nivolumab is administered at
a dose of 3 mg per kilogram of body weight every 2 weeks. Every 2 weeks of nivolumab as one course, patients receive nivolumab until disease progression, unacceptable toxic effects.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients in Recurrent or Metastatic after six months Squamous Cell Carcinoma of the Head and Neck who finished platinum-based chemotherapy
2) Histological proven squamous cell carcinoma of the head and neck
3) Primary site, maxillary sinus, oral cavity, epipharynx, oropharynx, hypopharynx or larynx
4) Age 20-75 years
5) Performance status (PS) 0-1
6) Adequate organ functions defined as indicated below before registration in 14 days
(1)WBC >= 3,500 /mm3 , WBC <= 12,000 /mm3
(2)neutrophil >= 2,000 /mm3
(3)Plt >= 100,000 /mm3
(4) Hb>= 9.0 g/ dL
(5) T.Bil <= 1.5 mg/dL
(6) AST(GOT) , ALT(GPT) <= 100 IU/L
(7) Cr < 1.2 mg/dL
7) Written informed consent
Key exclusion criteria
1) Patients with a past history of severe drug allergy of nivolumab and similar drug
2) Patients with a symptomatic brain metastasis and meningeal metastasis
3) Histological proven primary unknown squamous cell carcinoma, salivary gland cancer, non-squamous cell cancer.
4) Patients with a symptomatic autoimmune disease or history of Autoimmune disease.
5) Patients with infection
6) Patients with Gastrointestinal disease (Intestinal paralysis, Bowel obstruction)
7) Patients with Interstitial pneumonia or Pulmonary fibrosis
8) Uncontrolled diabetes
9) Uncontrolled heart disorder
10) Sever liver damage
11) Patients with diarrhea
12) Pregnant or lactating women or women of childbearing potential
13) Male expecting partner's pregnancy
14) Inadequate physical condition, as diagnosed by attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiyoaki |
| Middle name | |
| Last name | Tsukahara |
Organization
Tokyo Medical University
Division name
Division of Otorhinolarygology, Head and neck Surgery
Zip code
1600023
Address
6-7-1 Nishi-shinjuku, Shinjukuku, Tokyo 160-0023 Japan
TEL
03-3342-6111
tsuka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | isaku |
| Middle name | |
| Last name | Okamoto |
Organization
Tokyo Medical University
Division name
Division of Otorhinolarygology, Head and neck Surgery
Zip code
1600023
Address
6-7-1 Nishi-shinjuku, Shinjukuku, Tokyo 160-0023 Japan
TEL
03-3342-6111
Homepage URL
isaku@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
0333426111
Adm_IRB@tokyo-med.ac.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
| 2018 | Year | 02 | Month | 19 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035754
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/02/23 | ③プラチナ６M以降ニボルマブ実施計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/02/23 | 登録適格性確認票 ニボルマブ６Ｍ以降.docx |
| Research case data | |
|---|---|
| Registered date | File name |
