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 UMIN000034668
Receipt No. R000039522
Scientific Title A phase II study of IMRT with concurrent chemotherapy for esophageal cancer with stage I
Date of disclosure of the study information 2018/11/01
Last modified on 2019/01/11

* 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 A phase II study of IMRT with concurrent chemotherapy for esophageal cancer with stage I
Acronym IMRT for esophageal cancer with stage I
Scientific Title A phase II study of IMRT with concurrent chemotherapy for esophageal cancer with stage I
Scientific Title:Acronym IMRT for esophageal cancer with stage I
Region
Japan

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

Objectives
Narrative objectives1 to evaluate efficacy and safety of IMRT with concurrent chemotherapy (CDDP+5-FU) for stage I esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3-y progression-free survival rate
Key secondary outcomes Grade 2 or more adverse events and 3-y overall survival rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 IMRT without elective nodal irradiation
60Gy/30fractions
concurrent chemotherapy
5-FU 700mg/m2/day div(24h) day1-4,day29-32
CDDP 70mg/m2/day div(2h) day1,day29
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.histologically proven thoracic esophageal squamous cell carcinoma
2.T1a or T1b with ultrasound endoscopy
3.no lymph node metastases by CT and FDG-PET
4.aged between 20-y and 79-y
5.Performance Status (ECOG):0-2
6.no severe complication
7.no indication or refusal for EMR/ESD or 8.written informed consent
Key exclusion criteria 1.past EMR/ESD history for primary site
2.patient with intramural metastasis
3.past irradiation history for thoracic
4.patient with active malignant tumor
5.patient with severe complication
6.patient with active infection
7.patient with severe interstitial pneumonia
8.patient with ECD or pace maker

Target sample size 24

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Keiichi Jingu
Organization Tohoku Univeristy Hospital
Division name Department of Radiuation Oncology
Zip code
Address 1-1 Seiryou-chou, Aobaku
TEL 022-717-7312
Email kjingu-jr@rad.med.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Keiichi Jingu
Organization Tohoku university graduate school of Medicine
Division name Department of Radiuation Oncology
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai
TEL 022-717-7312
Homepage URL
Email kjingu-jr@rad.med.tohoku.ac.jp

Sponsor
Institute Tohoku Univeristy Hospital
Institute
Department

Funding Source
Organization Tohoku Univeristy Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Miyagi Prefecture Cancer Center
Name of secondary funder(s)

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 東北大学病院(宮城県)、宮城県立がんセンター(宮城県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2018 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 27 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039522

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.