UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

total treatment rate

Key secondary outcomes

response, advance events, PFS, OS

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kindai nara hospital

Institute

Department

Personal name

Organization

Kindai nara hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

05

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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