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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005877
Receipt No. R000006858
Scientific Title Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer
Date of disclosure of the study information 2011/07/01
Last modified on 2020/01/06

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Basic information
Public title Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer
Acronym ECDN
Scientific Title Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer
Scientific Title:Acronym ECDN
Region
Japan

Condition
Condition Advanced or recurrent esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes overall survival, one year survival rate, progression free survival, objective response rate, adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 NDP(80mg/m2) and DOC(60mg/m2) combination chemotherapy
Interventions/Control_2 DOC (70mg/m2) chemotherapy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.recurreent esophageal cancer
2.the tumor has a measurable lesion for evaluation.
3.5FU/CDDP resistance
4.ECOG PS:0 to 2
5.Age from 20 to 80 years
6.Adequate organ function
WBC:>3,000/ mm3 <12,000/mm3
Neutro:>1,500/mm3
Hb:>9.0 g/dl
Plt:>100,000/mm3
T-Bil:<1.5mg / dl
AST(GOT),ALT(GPT):within 2.5 times the normal upper limits
Ccr: 1.5mg/dl
C.Cr:>50ml / min (Cockcroft- Gault)
7. Written informed consent

Key exclusion criteria (1) patient who has drug allergy as past history
1. Known hypersensitivity to DOC, NDP and Polysorbate-80
2. patient who has active infectious disease
3. patient who has active double cancer
4. patient who has severe complication (interstitial pneumonitis, DM etc.)
5.concomitant treatment with steroids
6.EDEMA
7. patient who want to be pregnant and /or pregnant woman
8. patient who was judged to be unsuitable for this clinical trial
Target sample size 43

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Shimada
Organization Toho University School of Medicine
Division name Department of Surgery
Zip code 181-0001
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL 0422577669
Email yajiman68@yahoo.co.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Yajima
Organization Division of General and Gastroenterological Surgery, Department of Surgery (Omori), Toho University
Division name Department of Surgery
Zip code 143-8541
Address 6-11-1 Omori-nishi Ota-ku Tokyo Japan
TEL 0422577669
Homepage URL
Email yajiman68@yahoo.co.jp

Sponsor
Institute Toho University
Institute
Department

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 Toho Unoversity School of Medicine
Address 6-11-1 Omori-nishi Ota-ku Tokyo Japan
Tel 0337624151
Email yajiman68@yahoo.co.jp

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 07 Month 01 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 05 Month 16 Day
Date of IRB
2011 Year 05 Month 19 Day
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 08 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 29 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006858

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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