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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035781
Receipt No. 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

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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
Email 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
Email hi-ok-0531@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040696

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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