UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045299 |
|---|---|
| Receipt number | R000051739 |
| Scientific Title | Predicting tumor response to neoadjuvant chemotherapy in esophageal cancer patients-correlation between hypoxic imaging and signal transduction pathways |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/08/29 22:01:02 |
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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
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
kaida@med.kindai.ac.jp
Sponsor or person
Institute
Institute of Advanced Clinical Medicine, Kindai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051739
