UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of neoadjuvant chemoradiotherapy using Intensity Modulated Radiation Therapy (IMRT) with Docetaxel, CDDP and 5-Fluorouracil (DCF) for cervical esophageal cancer.
Title of the study (Brief title)	OCD1501
Region	Japan

Condition
Condition	cervical esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of preoperative chemoradiotherapy used Intensity Modulated Radiation Therapy:IMR and Docetaxcel/CDDP/5-FU(DCF) for patients with cervical esophageal cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	tbc
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 Device,equipment
Interventions/Control_1	Intensity Modulated Radiation Therapy (IMRT)with Docetaxcel/CDDP/5-FU(DCF)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically proven cervical esophageal cancer 2) Tumor progress range/cervical esophageal cancer: Ce, CePh 3) Tumor progress range/TNM: T1b,T2,T3,T4 4) Aged over 20 years at the time of registration Performance Status(ECOG):0 or 1 5) Adequate organ function 6) Written IC
Key exclusion criteria	1) History of serious drug hypersensitivity 2) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant 3) Active infections 4 4) Serious complications 5) Serious heart disease 6) Peptic ulcers 7) Sensory neuropathy 8) Diarrhea 9) A case with abdominal dropsy and the hydrothorax to need a treatment 10) Brain metastasis 11) Other active malignancies (Nondisease period less than 5 years) 12) Continuous steroid treatment 13) Any other cases who are regarded as inadequate for study enrollment by the investigator 14) Administration contraindication of 5-FU, CDDP, Docetaxel
Target sample size	6

Research contact person
Name of lead principal investigator	Makoto Sakai
Organization	Gunma University Hospital
Division name	Integrative Center of General Surgery
Address	3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8224
Email	maksakai@gunma-u.ac.jp

Public contact
Name of contact person	Makoto Sakai
Organization	Gunma University Hospital
Division name	Integrative Center of General Surgery
Address	3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8224
Homepage URL
Email	maksakai@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital
Institute
Department

Funding Source
Organization	n/a
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	2015 Year 07 Month 09 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 14 Day
Anticipated trial start date	2015 Year 05 Month 14 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 08 Day
Last modified on	2018 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020946