UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002249 |
|---|---|
| Receipt number | R000002754 |
| Scientific Title | FDG-PET for prediction of the efficacy of chemotherapy followed by chemoradiotherapy for Stage II/III esophageal cancer. |
| Date of disclosure of the study information | 2009/07/25 |
| Last modified on | 2022/02/02 09:24:54 |
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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
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
yamamoto-sa@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002754
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