UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024686 |
|---|---|
| Receipt number | R000028402 |
| Scientific Title | Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck |
| Date of disclosure of the study information | 2016/11/02 |
| Last modified on | 2016/11/02 16:45:50 |
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Basic information
Public title
Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck
Acronym
TPF study for Japanese
Scientific Title
Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck
Scientific Title:Acronym
TPF study for Japanese
Region
| Japan |
Condition
Condition
Locally advanced head and neck cancer
Classification by specialty
| Hematology and clinical oncology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the feasibility of TPF as induction chemotherapy for Japanese head and neck cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility of TPF
Key secondary outcomes
overall response rate to TPF
local recurrence-free survival
progression-free survival
overall survival
safety profile
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Induction chemotherapy(TPF)
Docetaxel: 70-75mg/m2, day1
Cisplatin: 70-75mg/m2, day1
Fluorouracil: 750mg/m2, day1-5
q3w, total 3cycles
Chemoradiotherapy(CRT)
Cisplatin: 20mg/m2, day1-4
q3w, total 3cycles
Radiation: 70Gy
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
Histologically confirmed Squamous cell carcinoma
Following primary sites: Larynx, Oropharynx and Hypopharynx
Unresectable locally advanced head and neck cancer
No metastasis
Age from 20 to 75
PS(ECOG): 0 or 1
No prior treatment of definitive operation
No prior treatment with systemic anti-cancer therapy, radiotherapy or hormone therapy
Adequate organ function
Signed informed consent
Key exclusion criteria
Active bacterial or fungus infection
Active Malignant disease, other than that being treated in this study
Pregnant or lactating women
Clinically significant and/or uncontrolled heart disease
History of cerebrovascular disease
Uncontrolled diabetes or hypertension
Severe complications
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Tahara |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Medical Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
matahara@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Okano |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Medical Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
sokano@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo Cancer Center Hospital
Jikei University School of Medicine Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 11 | Month | 02 | 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
| 2009 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 03 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 03 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 02 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028402
