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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022191
Receipt No. R000025562
Scientific Title A Phase II trial of Nedaplatin, 5FU and Docetaxel for induction chemotherapy with Local advanced squamous cell carcinoma of the Head and Neck
Date of disclosure of the study information 2016/05/09
Last modified on 2016/05/09

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Basic information
Public title A Phase II trial of Nedaplatin, 5FU and Docetaxel for induction chemotherapy with Local advanced squamous cell carcinoma of the Head and Neck
Acronym A Phase II trial of Nedaplatin, 5FU and Docetaxel for induction chemotherapy with Local advanced squamous cell carcinoma of the Head and Neck(UDON HeN)
Scientific Title A Phase II trial of Nedaplatin, 5FU and Docetaxel for induction chemotherapy with Local advanced squamous cell carcinoma of the Head and Neck
Scientific Title:Acronym A Phase II trial of Nedaplatin, 5FU and Docetaxel for induction chemotherapy with Local advanced squamous cell carcinoma of the Head and Neck(UDON HeN)
Region
Japan

Condition
Condition Local advanced squamous cell carcinoma of the Head and Neck
Classification by specialty
Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 safety and efficacy of nedplatin, 5FU and docetaxel with Local advanced squamous cell carcinoma of the Head and Neck
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes total treatment rate
Key secondary outcomes response, advance events, PFS, OS

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 5FU was administered by continuous infusion on days
1-5.The cycle was repeated every 4 weeks.
Docetaxel was infused over 60 min on days 1 and 15.The cycle was repeated every 4 weeks.
Nedaplatin was infused over 90 min on day 1. The cycle was repeated every 4 weeks.
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 Patients eligible for inclusion in this study were aged 20-75 years at the time of registration and were histologically or cytologically confirmed to have local advanced cancer with SCC. Inclusion criteria also included an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy of >12 weeks, as well as adequate liver, bone marrow, renal, and cardiovascular functions, as evidenced by the following measures: serum aspartate aminotransferase and alanine aminotransferase levels of less than or equal to twice the upper limit of normal range; platelet count. The presence of measurable disease was not a requirement to participate in this study.
Key exclusion criteria The major exclusion criteria were as follows: previous
treatment with cis-dichlorodiammineplatinum (II) (CDDP), 5-FU, and/or taxane therapy for recurrent disease or irradiation to major bone areas; serious concomitant malignancy; active infectious disease with fever; severe drug allergy; symptomatic peripheral neuropathy; uncontrolled diabetes mellitus, hypertension, angina pectoris, arrhythmia, or congestive heart failure; and interstitial pneumonia or lung fibrosis. Prior to study entry, all patients were required to sign an informed consent form approved by the Ethical Committee of Kinki University Hospital.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shinya ueda
Organization kindai nara hospital
Division name medical oncology
Zip code
Address 1248-1, otuta, ikoma city, nara
TEL 0743-77-0880
Email s-ueda@nara.med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name shinya ueda
Organization kindai nara hospital
Division name medical oncology
Zip code
Address 1248-1, otuta, ikoma city, nara
TEL 0743-77-0880
Homepage URL
Email s-ueda@nara.med.kindai.ac.jp

Sponsor
Institute Kindai nara hospital
Institute
Department

Funding Source
Organization Kindai nara hospital
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
Address
Tel
Email

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 05 Month 09 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
2016 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2016 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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