UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013852 |
|---|---|
| Receipt number | 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 | 2022/03/28 14:10:59 |
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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 | Hitoshi |
| Middle name | |
| Last name | Ishikawa |
Organization
National Institute 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
ishikawa.hitoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Ishikawa |
Organization
National Institute 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
ishikawa.hitoshi@qst.go.jp
Sponsor or person
Institute
National Institute for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute for Quantum and Radiological Science and Technology
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
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1, Anagawa, Inage-ku, Chiba
Tel
043-206-4706
helsinki@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
QST病院
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
| 2012 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 04 | Month | 30 | Day |
Last modified on
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015675
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