UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005083 |
|---|---|
| Receipt number | R000006044 |
| Scientific Title | the phase I study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer |
| Date of disclosure of the study information | 2011/02/14 |
| Last modified on | 2011/02/14 18:59:59 |
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Basic information
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
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
Objectives
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
Assessment
Primary outcomes
Decision of a recommended dosage
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
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
Eligibility
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
Research contact person
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
Public contact
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
Sponsor or person
Institute
Gunma University Graduate School Department of General Surgical Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
群馬大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 14 | 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
| 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
Other related information
Management 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
