UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II trial of Nedaplatin, 5FU and Docetaxel for induction chemotherapy with Local advanced squamous cell carcinoma of the Head and Neck
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	shinya ueda
Organization	kindai nara hospital
Division name	medical oncology
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	shinya ueda
Organization	kindai nara hospital
Division name	medical oncology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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