UMIN-CTR Clinical Trial

Basic information
Public title	Predicting tumor response to neoadjuvant chemotherapy in esophageal cancer patients-correlation between hypoxic imaging and signal transduction pathways
Acronym	Predicting tumor response to neoadjuvant chemotherapy in esophageal cancer patients-correlation between hypoxic imaging and signal transduction pathways
Scientific Title	Predicting tumor response to neoadjuvant chemotherapy in esophageal cancer patients-correlation between hypoxic imaging and signal transduction pathways
Scientific Title:Acronym	Predicting tumor response to neoadjuvant chemotherapy in esophageal cancer patients-correlation between hypoxic imaging and signal transduction pathways
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study to reveal whether pretreatment 18F-misonidazole (FMISO) PET/CT can predict tumor response to neoadjuvant chemotherapy (NAC) based on histopathological response in esophageal cancer patients. In addition, we reveal the correlation between FMISO uptake and tumor hypoxia or tumor immunity environment
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We investigate the diagnostic accuracy of pretreatment FMISO PET/CT to histopathologic response and Positron Emission Tomography (PET) Response Criteria in Solid Tumors.
Key secondary outcomes	(1)We investigate whether pretreatment FMISO PET/CT reflect tumor hypoxia or tumor immunity environment. (2)We investigate the relationship between pretreatment FMISO PET/CT and relapse-free survival (RFS).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	18F-misonidazole Duration: two days dose: 7.4Mbq/kg
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)Patient age less than 80 years old (2)Squamous cell carcinoma patient undergoing FDG-PET/CT before and after NAC (2 course of docetaxel, cisplatin, 5-flurouracil ; DCF) and surgical resection in our institution. (3)Performance status (ECOG) : 0-1
Key exclusion criteria	(1) Not received informed consent (2) Patient age less than 20 years old and more than 80 years old (3) Non-squamous cell carcinoma (4) Patient with synchronous cancer (5) Patient undergoing endoscopic mucosal resection (6) Patient undergoing chemoradiotherpy (7) Pregnant woman, lactating woman, possibility of pregnancy (8) Patient with serous complication affecting examination (9) inappropriate patient for this examination justified by attending physician
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hayato Middle name Last name Kaida
Organization	Institute of Advanced Clinical Medicine, Kindai University
Division name	Division of Positron Emission Tomography
Zip code	589-8511
Address	377-2 Ohnohigashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Email	kaida@med.kindai.ac.jp

Public contact
Name of contact person	1st name Hayato Middle name Last name Kaida
Organization	Institute of Advanced Clinical Medicine, Kindai University
Division name	Division of Positron Emission Tomography
Zip code	589-8511
Address	377-2 Ohnohigashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Homepage URL	https://www.med.kindai.ac.jp/pet/kindai_pet/overview.html
Email	kaida@med.kindai.ac.jp

Sponsor
Institute	Institute of Advanced Clinical Medicine, Kindai University
Institute
Department

Funding Source
Organization	Japan Society For The Promotion Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ethics Committee, Kindai University Faculty of Medicine
Address	377-2 Ohnohigashi, Osaka-Sayama, Osaka
Tel	072-366-0221
Email	zizen@med.kindai.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	2021 Year 11 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2027 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	2021 Year 08 Month 29 Day
Last modified on	2021 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051739