UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002249
Receipt No. 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 2013/07/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Ryu Ishihara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-3, Nakamichi 1 chome, Higashinari-ku, Osaka 537-8511
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sachiko Yamamoto
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
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
Address
Tel
Email

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
2013 Year 07 Month 29 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.