UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006615
Receipt number R000007823
Scientific Title Phase I/II study of docetaxel/nedaplatin/5-FU for advanced esophageal cancer
Date of disclosure of the study information 2011/10/26
Last modified on 2015/04/27 07:48:38

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Phase I/II study of docetaxel/nedaplatin/5-FU for advanced esophageal cancer

Acronym

Phase I/II study of DNF for advanced esophageal cancer

Scientific Title

Phase I/II study of docetaxel/nedaplatin/5-FU for advanced esophageal cancer

Scientific Title:Acronym

Phase I/II study of DNF for advanced esophageal cancer

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Feasibility and effectivenes of DNF therapy for esophageal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

PI
Primary endpoint:DLT

PII
Primary endpoint:PFS

Key secondary outcomes

PI:
Secondary endpoints:AE,RR
PII:
Secondary endpoints:RR,OS,AE


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

Docetaxel, nedaplatin, 5-FU

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

1)SCC< Adenosquamous, or basaloid cacinoma
2)Inoperable cases
3)no esophago bronchial fistula, no esophago-mediastinal fistula
4)There were not more than 2 protocols of chemotherapy including CDDP.
5) age 20 and more, 75 and less.
6) PS0-1
7) There are mesurable lesions
8)Adequate organ functions
9)Written informed consent

Key exclusion criteria

1) other active cancers
2) patients who want to be pregnant or pregnant woman
3)severe pshychological disorder
4) prior or current history of steroidal treatments
5) HBsAG(+)
6) Severe DM
7) History of Severe complications
8) History of cardiac infarction
9)Acative infection
10)inappropriate cases for a clinical trials

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisahiro Matsubara

Organization

Chiba University

Division name

Frontier Surgery

Zip code


Address

1-8-1, Inohana, Chuoku, Chiba, Japan

TEL

043-222-7171

Email

yakutsu@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasunori Akutsu

Organization

Chiba University

Division name

Fronteir Surgery

Zip code


Address

1-8-1, Inohana, Chuoku, Chiba

TEL

043-226-2110

Homepage URL


Email

yakutsu@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2011 Year 10 Month 26 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

2011 Year 10 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 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

2011 Year 10 Month 26 Day

Last modified on

2015 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007823


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name