UMIN-CTR Clinical Trial

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

Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013552
Receipt No. R000015666
Scientific Title A phase I/II clinical trial of carbon-ion therapy for patients with clinical stage I squamous cell carcinoma of the thoracic esophagus
Date of disclosure of the study information 2014/03/31
Last modified on 2019/10/04

* 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 I/II clinical trial of carbon-ion therapy for patients with clinical stage I squamous cell carcinoma of the thoracic esophagus
Acronym A phase I/II clinical trial of carbon-ion radiotherapy for stage I esophageal squamous cell carcinoma
Scientific Title A phase I/II clinical trial of carbon-ion therapy for patients with clinical stage I squamous cell carcinoma of the thoracic esophagus
Scientific Title:Acronym A phase I/II clinical trial of carbon-ion radiotherapy for stage I esophageal squamous cell carcinoma
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and therapeutic effect of carbon-ion radiotherapy for stage I thoracic esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Acute adverse events
Response rate
Key secondary outcomes Local control rate
Survival rate
Late adverse events

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 Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Carbon-ion radiotherapy: in 12 fractions over 3 weeks.
The total radiation dose is escalated from the initial dose of 43.2 GyE.
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

Not applicable
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically proven squamous cell carcinoma of the thoracic esophagus
2.Clinical stage I (T1bN0M0) according to the Japanese classification of esophageal cancer (10th edition)
3.Measurable lesion
4.Age of 80 years or younger
5.Performance status between 0 and 2
6.Written informed consent
Key exclusion criteria 1.Ttumor size more than 8 cm
2.Intramural metastasis
3.Prior treatments for the esophageal lesion
4.Previous radiotherapy in the treatment area
5.Other active cancer
6.Active infection
7.Serious medical or psychological problems

Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shigeo
Middle name
Last name Yasuda
Organization National Institutes for Quantum and Radiological Science and Technology
Division name QST Hospital
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba
TEL 043-206-3306
Email yasudash@qst.go.jp

Public contact
Name of contact person
1st name Shigeo
Middle name
Last name Yasuda
Organization National Institutes for Quantum and Radiological Science and Technology
Division name QST Hospital
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba
TEL 043-206-3306
Homepage URL
Email yasudash@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the NIRS Ethics Committee on Human Clinical Research
Address 4-9-1, Anagawa, Inage-ku, Chiba
Tel 043-206-3193
Email genkoba@qst.go.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
2014 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2008 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2018 Year 12 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
2014 Year 03 Month 28 Day
Last modified on
2019 Year 10 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.