UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035781 |
|---|---|
| Receipt number | R000040696 |
| Scientific Title | A randomized phase II study of robot-assisted thoracoscopic versus thoracoscopic esophagectomy for patients with curative surgery for thoracic esophageal cancer |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2019/02/15 00:28:03 |
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Basic information
Public title
A randomized phase II study of robot-assisted thoracoscopic versus thoracoscopic esophagectomy for patients with curative surgery for thoracic esophageal cancer
Acronym
RATE for TEC
Scientific Title
A randomized phase II study of robot-assisted thoracoscopic versus thoracoscopic esophagectomy for patients with curative surgery for thoracic esophageal cancer
Scientific Title:Acronym
RATE for TEC
Region
| Japan |
Condition
Condition
Thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of robot assisted thoracoscopic esophagectomy compared with thoracoscopic esophagectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of Grade I or more postoperative recurrent nerve paralysis in Clavien-Dindo classification
Key secondary outcomes
1) Grade II and more total complications in Clavien-Dindo classification, 2) Operation time, 3) Blood loss, 4) Number of dissected mediastinum lymph node, 5) Change of surgical method, 6) Intraoperative adverse event, 7) Postoperative hospital stay , 8) QOL score (EORTC QLQ-C30, EORTC QLQ-OES18, EQ-5D-5L), 9) Operation related death, 10) Recurrent free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Thoracoscopic esophagectomy for thoracic esophageal cancer
Interventions/Control_2
Robot assisted thoracoscopic esophagectomy for thoracic esophageal cancer
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) Clinical stage I,II,III(excluding T4), UICC-TNM 8th, 4) Surgery approached from the neck, chest and abdomen (R0 resection) with D2 dissection followed by gastric conduit reconstruction, 5) >20 and <80 y.o., 6) ECOG-PS 0 or 1, 7) BMI >17 and <30, 8) No history of surgery for esophageal cancer, 9 ) No history of chemotherapy or radiotherapy, 10) No history of right thoracotomy or left lung lobectomy, 11) FEV1.0 >1.0L, 12) a) WBC >2000 and <10000/mm3, b) PLT >50000/mm3, c) Hb >10.0 g/dl, d) AST <100 IU/L, ALT <100IU/L, e) T-Bil <2.0 g/dl, f) Cre <1.5mg/dl, g) SpO2 >95%, 13) Written consent
Key exclusion criteria
1) Excision of other organs excluding gall bladder, 2) Active double cancer, 3) Pregnancy or breast-feeding, 4) Psychosis or mental symptoms, 5) Systemic administration of steroids, 6) History of myocardial infarction or unstable angina, 7) Poorly controlled hypertension, 8) Poorly controlled diabetes, 9) Respiratory disease requiring sustained oxygen therapy.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamei |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Okamoto |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7214
Homepage URL
hi-ok-0531@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
University grants of Tohoku University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | 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
| 2019 | Year | 02 | Month | 05 | Day |
Last modified on
| 2019 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040696
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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