UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001626 |
|---|---|
| Receipt number | R000001954 |
| Scientific Title | Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer |
| Date of disclosure of the study information | 2009/01/07 |
| Last modified on | 2019/09/19 16:32:12 |
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Basic information
Public title
Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Acronym
Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Scientific Title
Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Scientific Title:Acronym
Neoadjuvant chemoradiotherapy followed by esophagectomy for REG I positive T4, N4 or many thoracic esophageal cancer
Region
| Japan |
Condition
Condition
thoracic esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test that patients with T4 or N-many thoracic esophageal cancer expressing REG I in untreated endoscopic biopsy specimens achieved long-term survival when treated with neoadjuvant CRT followed by esophagectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
esophagectomy with lymph nodes dissection
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) primary squamous cell carcinoma of thoracic esophagus
(2) clinical-T4, clinical-N4 or N-many
(3) ECOG-PS 0,1,2
(4) resectable esophageal cancer
(5) Cr<1.2 mg/dl, BUN<25 mg/dl, 24h CCr>60 ml/min, T.Bil<1.2 mg/dl, GOT and GPT<100 IU, WBC>4,000 /mm3, Hb>10 g/dl, Plt>100,000 /mm3, PaO2>70 torr
Key exclusion criteria
(1) treatment history of chemotherapy or radiotherapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Motoyama |
Organization
Akita University School of Medicine
Division name
Department of Surgery
Zip code
0108543
Address
1-1-1 Hondo, Akita
TEL
018-884-6132
motoyama@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Motoyama |
Organization
Akita University School of Medicine
Division name
Department of General Affairs
Zip code
0108643
Address
1-1-1 Hondo, Akita
TEL
018-834-1111
Homepage URL
soumu@hos.akita-u.ac.jp
Sponsor or person
Institute
The Cancer Board of Esophageal Cancer in Akita University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Akita University School of Medicine
Address
1-1-1 Hondo, Akita
Tel
018-834-1111
soumu@hos.akita-u.ac.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
| 2009 | Year | 01 | Month | 07 | 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
| 2008 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | 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
| 2009 | Year | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001954
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
