UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004435 |
|---|---|
| Receipt number | R000005304 |
| Scientific Title | Phase II study of chemoradiotherapy using localized irradiation field for T1-3N0M0 esophageal carcinoma. |
| Date of disclosure of the study information | 2010/10/25 |
| Last modified on | 2014/10/24 18:19:14 |
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Basic information
Public title
Phase II study of chemoradiotherapy using localized irradiation field for T1-3N0M0 esophageal carcinoma.
Acronym
Phase II study of localized-field chemoradiotherapy for esophageal carcinoma.
Scientific Title
Phase II study of chemoradiotherapy using localized irradiation field for T1-3N0M0 esophageal carcinoma.
Scientific Title:Acronym
Phase II study of localized-field chemoradiotherapy for esophageal carcinoma.
Region
| Japan |
Condition
Condition
Esophageal carcinoma
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate merit and demerit of localized-irradiation field for early esophageal carcioma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Recurrence-free survival,
Incidence of adverse effects
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 | Maneuver | Other |
Interventions/Control_1
Chemoradiotherapy(CDDP+5FU+60Gy/30fr.)
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
- T1-3N0M0 untreated esophageal squamous cell carcinoma
- Negative lymph node metastasis by PET
- Performancestatus 0-1
- 20 - 75 years old
- Sufficient liver and renal functions
- Written informed consent is obtained
Key exclusion criteria
- Multiple or skip lesions
- Prior thoracic irradiation or chemotherapy
- Prior esophageal EMR
- Synchronous malignancies
- Uncontrolled severe complications
- Possibility of pregnancy
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Nemoto |
Organization
Yamagata University School of Medicine
Division name
Department of Radiation Oncology
Zip code
Address
2-2-2, Iida-nishi, Yamagata city, Yamagata, 990-9585, Japan
TEL
+81-23-628-5386
knemoto@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Nemoto |
Organization
Yamagata University School of Medicine
Division name
Department of Radiation Oncology
Zip code
Address
2-2-2, Iida-nishi, Yamagata city, Yamagata, 990-9585, Japan
TEL
+81-23-628-5386
Homepage URL
knemoto@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology, Yamagata University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (A): The Ministry of Education, Culture, Sports, Science and Technology.
Grant-in-Aid: Japanese Radiation Oncology Study Group.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
山形大学病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 24 | Day |
Last modified on
| 2014 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005304
