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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013852
Receipt No. R000015675
Scientific Title A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III squamous cell carcinoma of the thoracic esophagus
Date of disclosure of the study information 2014/04/30
Last modified on 2016/04/18

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Basic information
Public title A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III squamous cell carcinoma of the thoracic esophagus
Acronym A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III esophageal squamous cell carcinoma
Scientific Title A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III squamous cell carcinoma of the thoracic esophagus
Scientific Title:Acronym A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III 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 preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III thoracic esophageal squamous cell carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Acute adverse events
Response rate
Key secondary outcomes Late adverse events
Postoperative complications
Survival rate

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
Medicine Device,equipment Maneuver
Interventions/Control_1 1.Preoperative carbon-ion radiotherapy and concurrent chemotherapy.
Carbon-ion radiotherapy is administered in 8 fractiss over 2 weeks.
Chemothrapy consists of Cisplatin 70 mg/m2/day on days 1 and 22 and 5-FU 700 mg/m2/day on days 1-4 and 22-25.
2.Eesophagectomy and LN dissection is performed within 8weeks after the completion of preoperatve treatment.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically proven squamous cell carcinoma of the thoracic esophagus
2.Clinical stage II or III (sxcluding T4) according to the Japanese classification of esophageal cancer (10th edition)
3.Measurable lesion
4.Age between 20 and 75years old
5.Performance status between 0 and 2
6.Curatively resectable
7.No previous treatments for the esophageal lesion
8.Adequate organ (bone marrow, liver, kidney and so on) functions
9.Written informed consent
Key exclusion criteria 1.Past hisotry of radiotherapy in the treatment area
2.Other active cancer
3.Active interstitial pneumonia
4.Active infection in the treatment area
5.HBs-Ag positive, HCV-Ab positive, HIV-Ab positive, HTKLV-1-Ab positive
Target sample size 30

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

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

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 30 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
2012 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 09 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
2014 Year 04 Month 30 Day
Last modified on
2016 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015675

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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