UMIN-CTR Clinical Trial

Basic information
Public title	Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Acronym	Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Scientific Title	Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Scientific Title:Acronym	Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Region	Japan

Condition
Condition	thoracic esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test that patients with T4 or N-many thoracic esophageal cancer expressing REG I in untreated endoscopic biopsy specimens achieved long-term survival when treated with neoadjuvant CRT followed by esophagectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	overall survival
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	Maneuver
Interventions/Control_1	esophagectomy with lymph nodes dissection
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) primary squamous cell carcinoma of thoracic esophagus (2) clinical-T4, clinical-N4 or N-many (3) ECOG-PS 0,1,2 (4) resectable esophageal cancer (5) Cr<1.2 mg/dl, BUN<25 mg/dl, 24h CCr>60 ml/min, T.Bil<1.2 mg/dl, GOT and GPT<100 IU, WBC>4,000 /mm3, Hb>10 g/dl, Plt>100,000 /mm3, PaO2>70 torr
Key exclusion criteria	(1) treatment history of chemotherapy or radiotherapy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Motoyama
Organization	Akita University School of Medicine
Division name	Department of Surgery
Zip code	0108543
Address	1-1-1 Hondo, Akita
TEL	018-884-6132
Email	motoyama@doc.med.akita-u.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Motoyama
Organization	Akita University School of Medicine
Division name	Department of General Affairs
Zip code	0108643
Address	1-1-1 Hondo, Akita
TEL	018-834-1111
Homepage URL
Email	soumu@hos.akita-u.ac.jp

Sponsor
Institute	The Cancer Board of Esophageal Cancer in Akita University Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Akita University School of Medicine
Address	1-1-1 Hondo, Akita
Tel	018-834-1111
Email	soumu@hos.akita-u.ac.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	2009 Year 01 Month 07 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	Terminated
Date of protocol fixation	2008 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 01 Month 07 Day
Last modified on	2019 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001954