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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034668
Receipt No. R000039522
Official scientific title of the study 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 2018/10/27

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Basic information
Official scientific title of the study A phase II study of IMRT with concurrent chemotherapy for esophageal cancer with stage I
Title of the study (Brief title) 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
Name of lead principal investigator Keiichi Jingu
Organization Tohoku Univeristy Hospital
Division name Department of Radiuation Oncology
Address 1-1 Seiryou-chou, Aobaku
TEL 022-717-7312
Email kjingu-jr@rad.med.tohoku.ac.jp

Public contact
Name of contact person Keiichi Jingu
Organization Tohoku university graduate school of Medicine
Division name Department of Radiuation Oncology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 26 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information

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


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