UMIN-CTR Clinical Trial

Basic information
Public title	FDG-PET for prediction of the efficacy of chemotherapy followed by chemoradiotherapy for Stage II/III esophageal cancer.
Acronym	FDG-PET for prediction of the efficacy of chemoradiotherapy.
Scientific Title	FDG-PET for prediction of the efficacy of chemotherapy followed by chemoradiotherapy for Stage II/III esophageal cancer.
Scientific Title:Acronym	FDG-PET for prediction of the efficacy of chemoradiotherapy.
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate an association between FDG-PET finding during induction chemotherapy and the efficacy of chemoradiation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	An association between FDG-PET finding during induction chemotherapy and the efficacy of chemoradiotherapy (CR or Non-CR).
Key secondary outcomes	An association between FDG-PET finding during induction chemotherapy and overall survival. An association between FDP-PET finding during induction chemotherapy and disease-free survival. Safety. Optimal cut off value to predict CR Adverse event.

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	FDG-PET was performed before and after inductuion chemotherapy
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)Stage II/III (Excluding T4) esophageal cancer. (2)Inclusion criteria 1)Lesion mainly located in the thoracic esophagus. Histologically proven squamous cell carcinoma. 2)No previous chemotherapy against any cancer. 3)Aged 20 to 80 years old 4)ECOG Performance status 0 or 1. 5)Written informed consent. 6)Adequate organ functions.
Key exclusion criteria	1)Esophageal cancer spreading to pharynx or stomach. 2)Simultaneous double cancers. 3)Previous radiotherapy against cancer of thoracic cavity. 4)Uncontrollable complicating disease. 5)Interstitial pneumonia, fibroid lung. 6)History of collagen disease. 7)Psychosis. 8)Active infection which should be treated. 9)HBs antigen positive. HCV positive, TPHA positive, HIV positive 10)Women during pregnancy or breast-feeding. Men expecting to have a child.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ryu Middle name Last name Ishihara
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Zip code	5418567
Address	3-3, Nakamichi 1 chome, Higashinari-ku, Osaka 537-8511
TEL	06-6972-1181
Email	ryu1486@gmail.com

Public contact
Name of contact person	1st name Sachiko Middle name Last name Yamamoto
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Zip code	5418567
Address	3-3, Nakamichi 1 chome, Higashinari-ku, Osaka 537-8511
TEL	06-6972-1181
Homepage URL
Email	yamamoto-sa@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Osaka International Cancer Institute
Address	3-1-69, Otemae, Chuoku, Osaka
Tel	06-6945-1181
Email	rinri01@opho.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 07 Month 25 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	Open public recruiting
Date of protocol fixation	2009 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2013 Year 07 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2018 Year 12 Month 01 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2009 Year 07 Month 25 Day
Last modified on	2022 Year 02 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002754