UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020535
Receipt number 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 18:18:03

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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 or person

Institute

Hirosaki University Hospital

Institute

Department

Personal name



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

Value
https://center6.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