UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031146 |
|---|---|
| Receipt number | R000035515 |
| Scientific Title | Assessment of the efficacy and safety of 5-FU/CDDP/Cetuximab (FPE) induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2022/08/11 21:00:32 |
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Basic information
Public title
Assessment of the efficacy and safety of 5-FU/CDDP/Cetuximab (FPE) induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
Acronym
Assessment of the efficacy and safety of FPE induction chemotherapy in patients with LASCCHN
Scientific Title
Assessment of the efficacy and safety of 5-FU/CDDP/Cetuximab (FPE) induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
Scientific Title:Acronym
Assessment of the efficacy and safety of FPE induction chemotherapy in patients with LASCCHN
Region
| Japan |
Condition
Condition
locally advanced head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate of consecutive 3 courses
Key secondary outcomes
safety(CTCAE), progression free survival, compliance(dose intensity)
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
5-FU 800mg/sqr day1-4
CDDP 80mg/sqr day1
Cetuximab 250mg/sqr(initial dose only:400mg/sqr)day1, 8, 15
every 21 days
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
patients with locally advanced head and neck squamous cell carcinoma(primary cite: larynx, oropharynx and hypopharynx. /N classification: N2, N2b, N2c and N3)
Key exclusion criteria
Performance status 2 and more
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Kuratomi |
Organization
Saga University
Division name
Department of Otolaryngology - Head & Neck Surgery
Zip code
8498501
Address
5-1-1, Nabeshima, Saga-city
TEL
0952-34-2379
kuratomy@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Moriyasu |
| Middle name | |
| Last name | Yamauchi |
Organization
Saga University
Division name
Department of Otolaryngology - Head & Neck Surgery
Zip code
8498501
Address
5-1-1 Nabeshima, Saga-city
TEL
0952-34-2379
Homepage URL
yamamori@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
5-1-1 Nabeshima
Tel
0952-34-3400
none
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 | 05 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 08 | 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 | 05 | Day |
Last modified on
| 2022 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035515
