UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000006858