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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020535
Receipt No. R000023711
Scientific Title A Phase II study of robot-assisted colorectal cancer surgery
Date of disclosure of the study information 2016/01/12
Last modified on 2016/01/12

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Basic information
Public title A Phase II study of robot-assisted colorectal cancer surgery
Acronym robot-assisted colorectal cancer surgery study
Scientific Title A Phase II study of robot-assisted colorectal cancer surgery
Scientific Title:Acronym robot-assisted colorectal cancer surgery study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to explore the safety and efficacy of obot-assisted colorectal cancer surgery with da Vinci surgical system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Grade 3 or higher surgical complications (Clavien-Dindo Classification)
Key secondary outcomes Grade 2 or higher surgical complications (Clavien-Dindo Classification), medical care cost, obot-assisted colorectal cancer surgery completion rate, With or without conversion from obot-assisted surgery to open surgery, adverse event during surgery, performance of surgery, early postoperative course, surgery-related death, relapse free survival

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
Device,equipment
Interventions/Control_1 obot-assisted colorectal cancer surgery with lymph node 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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed Rectum adenocarcinoma
2) Without liver, peritoneum and distant metastases
3)Age of 20-80 years
4) without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy)
5)Aadequate function of important organs
1. WBC: >=3, 000/mm3 and 12,000/mm3
2. Neutrophil: >=1,500/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. AST, ALT: <100IU/L
6. T Bil: <=2.0mg/dL
7. Serum creatinine: <=1.2mg.DL
6) ECG: without clinically problematic abnormalities within 28 days before registration
7) Eastern Cooperative Oncology Group performance status (PS) 0-1
8) With ability of oral intake
9) Written informed concent
Key exclusion criteria 1) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
2) with active double cancer
3) had active infection disease (over 38.0 degree)
4) with psychosis or psychological symptom
5) Physician will determine that the patient is inappropriate participate in this trail for the safety.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Morohashi
Organization Hirosaki University Hospital
Division name Hirosaki University Hospital
Zip code
Address Hontyo53, Hiroski City, Aomori Pref.
TEL 0172-33-5111
Email hm2002@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Morohashi
Organization Hirosaki University Hospital
Division name Hirosaki University Hospital
Zip code
Address Hontyo53, Hiroski City, Aomori Pref.
TEL 0172-33-5111
Homepage URL
Email hm2002@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Hospital
Institute
Department

Funding Source
Organization non
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 12 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
2016 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 18 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
2016 Year 01 Month 12 Day
Last modified on
2016 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023711

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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