UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005446
Receipt number R000006459
Scientific Title A phase I/II study of docetaxel, nedaplatin and 5-fluorouracil with concurrent radiotherapy(DNF-R) in patients with esophageal cancer
Date of disclosure of the study information 2011/04/14
Last modified on 2015/10/14 17:33:43

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Basic information

Public title

A phase I/II study of docetaxel, nedaplatin and 5-fluorouracil with concurrent radiotherapy(DNF-R) in patients with esophageal cancer

Acronym

A phase I/II study of DNF-R in patients with esophageal cancer

Scientific Title

A phase I/II study of docetaxel, nedaplatin and 5-fluorouracil with concurrent radiotherapy(DNF-R) in patients with esophageal cancer

Scientific Title:Acronym

A phase I/II study of DNF-R in patients with esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The object of this phase I/II study is to determine the recommended dose (RD) of docetaxel by dose escalation in concurrent chemoradiotherapy with docetaxel/5-FU/ nedaplatin for the treatment of esophageal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Phase I
To determine the recommended dose (RD)
Phase II
Safety, Tumor responses

Key secondary outcomes



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

Chemotherapy of docetaxel, nedaplatin and 5-fluorouracil with concurrent radiotherapy

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

78 years-old >

Gender

Male and Female

Key inclusion criteria

(1) histologically proven esophageal cancer;
(2) clinical stage I to IV A (UICC-TMN)(phase I)
(3) an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
(4) age 20; 78 years;
(5) adequate baseline bone marrow function, adequate hepatic function
adequate renal function, adequate respiratory and cardiac function.
(6) a life expectancy of at least 3 months.

(7) Written informed consent was obtained from all patients.

Key exclusion criteria

(1) No prior chemotherapy regimen.
(2) history of drug hypersensitivity.
(3) active concomitant malignancy.
(4) serious complications (severe heart disease, active infection)
(5) pregnant or lactating females.
(6) The investigator considers not suitable for the study.

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasushi Sato

Organization

Sapporo Medical University
School of Medicine

Division name

Dept. of Internal Medicine(4)

Zip code


Address

S1W17, Chuo-ku, Sapporo, Japan

TEL

011-611-2111

Email

yasushis@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasushis Sato

Organization

Sapporo Medical University School of Medicine

Division name

Dept. of Internal Medicine(4)

Zip code


Address

S1W17, Chuo-ku, Sapporo, Japan

TEL

011-611-2111

Homepage URL


Email

yasushis@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)

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 04 Month 14 Day


Related information

URL releasing protocol


Publication of results

Published


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

2009 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 04 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 04 Month 14 Day

Last modified on

2015 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006459


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name