UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022191 |
|---|---|
| Receipt number | 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 18:32:32 |
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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
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
s-ueda@nara.med.kindai.ac.jp
Sponsor or person
Institute
Kindai nara hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025562
