UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of neoadjuvant chemotherapy with docetaxel/CDGP/5-fluorouracil in resectable esophagus cancer
Acronym	DNF-NAC for resectable esophagus cancer
Scientific Title	Feasibility study of neoadjuvant chemotherapy with docetaxel/CDGP/5-fluorouracil in resectable esophagus cancer
Scientific Title:Acronym	DNF-NAC for resectable esophagus cancer
Region	Japan

Condition
Condition	esophagus cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the feasibility and efficacy, we conduct neoadjuvant docetaxel/CDGP/5-FU(DNF)chemotherpy for operable esophagus cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Completion rate of protocol treatment
Key secondary outcomes	Safety Progression-free survival Overall survival R0 resection rate Operative morbidity

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	Chemotherapy using docetaxel,CDGP,5-FU followed by surgical resection
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven esophageal squamous cell carcinoma. 2) Patients who are going to undergo curative esophagectomy with 2F or 3F lymph node dissection. 3) TNM stage Ib-III 4) Performance status 0-2 ECOG 5) Tolerable function of bone marrow,liver and kidney.
Key exclusion criteria	(1) No prior chemotherapy regimen. (2) history of drug hypersensitivity. (3) active concomitant malignancy. (4) serious complications (severe heart disease, active infection) (5) pregnant or lactating females. (6) The investigator considers not suitable for the study.
Target sample size	28

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroyuki Ohnuma
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
Zip code
Address	S-1,W-16,Sapporo
TEL	011-611-2111
Email	ohnuma@sapmed.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroyuki Ohnuma
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
Zip code
Address	S-1,W-16,Sapporo
TEL	011-611-2111
Homepage URL
Email	ohnuma@sapmed.ac.jp

Sponsor
Institute	Department of Medical Oncology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Department of Medical Oncology, Sapporo Medical University School of Medicine
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
Address
Tel
Email

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 06 Month 18 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	Main results already published
Date of protocol fixation	2014 Year 05 Month 15 Day
Date of IRB	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 05 Month 15 Day
Last follow-up date	2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 18 Day
Last modified on	2019 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016646