UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	For advanced or recurrent esophageal cancer Of combination therapy - docetaxel-cisplatin-5 fluorouracil phase I/II trial
Title of the study (Brief title)	Bi-weekly DCF therapy for esophageal cancer PI/II study
Region	Japan

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

Objectives
Narrative objectives1	Consider safety fluorouracil in combination therapy (DCF therapy), optimum dosage, effectiveness - docetaxel, cisplatin, 5-fluorouracil intended for advanced or recurrent esophageal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint estimate the optimal dose of docetaxel in combination therapy in CF. consider kind of side effects, the severity. Secondary endpoints To examine the anti-tumor effect and incidence of adverse events.
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	docetaxel cisplatin 5-Fu
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	Patients with evaluable lesions or measurable Patients have been identified with esophageal cancer histologically Case found that there is no effect of previous treatment.
Key exclusion criteria	Cases with (heart disease, interstitial pneumonitis or pulmonary fibrosis, and cirrhosis of the liver) complications serious. patients with serious infections Patients with edema required Treatment Cases with non-pleural effusion control, ascites Patients with a history of drug hypersensitivity serious. Cases there is a possibility that pregnant women, pregnant and lactating women. Cases is determined participation in the test is difficult and complicated by psychiatric symptoms or psychosis Patients undergoing (oral or intravenous) systemic continuous administration ofsteroid Cases attending physician was deemed inappropriate In carrying out Other, this clinical trial.
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshihiro Tanaka
Organization	Gifu University
Division name	Surgical Oncology
Address	1-1 Yanagido Gifu City
TEL	0582306000
Email	yoshihirotana11@hotmail.com

Public contact
Name of contact person	Yoshihiro Tanaka
Organization	Gifu University
Division name	Surgical Oncology
Address	1-1 Yanagido Gifu City
TEL	0582306000
Homepage URL
Email	yoshihirotana11@hotmail.com

Sponsor
Institute	gifu University
Institute
Department

Funding Source
Organization	self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 07 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 01 Month 07 Day
Anticipated trial start date	2009 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 23 Day
Last modified on	2017 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017015