UMIN-CTR Clinical Trial

Public title

the phase I study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer

Acronym

the phase I study of DNF therapy to esophageal cancer

Scientific Title

the phase I study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer

Scientific Title:Acronym

the phase I study of DNF therapy to esophageal cancer

Region

Japan

Condition

StageII,III,IV non-resective esophageal cancer and recurrece ofesophageal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We aim at setting up the recommendation dosege of Docetaxel, Nedaplatin and 5-Fluorouracil combination chemotherapy to patient with esophageal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Decision of a recommended dosage

Key secondary outcomes

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

2008/8-2010/8
nedaplatin 60-80mg/m2
Doc 50-70mg/m2
5FU 600-800mg/m2/day

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

1.It is diagnosed as an esophageal carcinoma for histopathology or cytology.
2.It is advanced unresectable esophageal cancer (StageII, III or IV) or esophageal carcinoma recurrent.
3.the interval between last treatment(radiation, chemotherapy) and this study is 4 weeks or more.
4.There is evaluable lesion for treatment.
5.ECOG Performance status is 0-2.
6.We satisfy all the following conditions.
that examination of an equal day two weeks of registration day ago permits it
(1)4,000 white blood corpuscle >= /mm3 and 12,000 <= /mm3
(2)2,000 mature granulocyte >= /mm3
(3)100,000 blood platelet >= /mm3
(4)Haemoglobin >= 9.5g/dL
(5)1.5 fold upper limit in the hospital AST <= IU/L
(6)1.5 fold upper limit in the hospital ALT <= IU/L
(7)Bilirubin total <= 1.5mg/dL
(8)2.5 fold upper limit in the hospital Al-P <= IU/L
(9)Creatinine <= 1.2mg/dL
(10)PaO2 >= 60 torr (room air)
7.expected prognosis is 3 months or more.
8.About final examination participation, an agreement by a document from the person himself is obtained.

Key exclusion criteria

1.It is the patient having an anaphylactic history for DOC, CDGP, 5-FU and polysorbate "80" component pharmaceutical.
2.Severe complicate disease (malignant hypertension, severe heart failure, liver failure, liver cirrhosis, diabetes mellitus under inadequate control, bleeding disorders)
3.Infectious disease with fever up
4.Regardless of presence of a cause, it is motor paralysis, the patient having peripheral neuropathy, severe edema
5.pleural effusion or cardiac effusion need to treatment.
6.The patient having active multiple primary cancer.
7.During the pregnancy or a pregnant female patient we are possible or are nursing.
8.The patient having the interstitial pneumonia that is apparent by chest X-rays or CT or pulmonary fibrosis
9.The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination.
10.the case that resarch contact doctor regards as inadequate.

Target sample size

18

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuya Miyazaki

Organization

Gunma University Graduate School

Division name

Department of General Surgical Science

Zip code

Address

3-39-22 Showa-machi, Maebashi-shi, Gunma

TEL

Email

Name of contact person

1st name
Middle name
Last name	Tatsuya Miyazaki

Organization

Gunma University Graduate School

Division name

Department of General Surgical Science

Zip code

Address

3-39-22 Showa-machi, Maebashi-shi, Gunma

TEL

Homepage URL

Email

Institute

Gunma University Graduate School Department of General Surgical Science

Institute

Department

Personal name

Organization

none

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

群馬大学医学部付属病院

Date of disclosure of the study information

2011

Year

02

Month

14

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

Completed

Date of protocol fixation

2008

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2008

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

14

Day

Last modified on

2011

Year

02

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006044