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Phase II Study for Robot Assisted Distal Gastrectomy (RADGphaseII)

Primary Purpose

Early Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Robot assisted distal gastrectomy (DaVinci)
Sponsored by
Shizuoka Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Gastric Cancer focused on measuring DaVinci, Robot assisted surgery, Gastrectomy, Safety, Gastric Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Biopsy specimen from the primary lesion shows adenocarcinoma
  2. Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
  3. Endoscopic submucosal dissection is not indicated
  4. Tumor was located within lower two thirds of stomach
  5. Not having duodenal invasion
  6. Eastern clinical oncology group performance status is 0 or 1
  7. Body mass index is lower than 30
  8. No prior laparotomy
  9. No prior chemotherapy or radiation including those for other cancers
  10. Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl

Exclusion Criteria:

  1. Having other active cancers
  2. Possibly pregnant, or breast feeding woman
  3. with psychiatric disorder
  4. Receiving steroids
  5. With Acute myocardial infarction in 6 months or with unstable angina
  6. With uncontrolled hypertension
  7. With uncontrolled diabetes mellitus
  8. With pulmonary disease which require continuous oxygen therapy

Sites / Locations

  • Shizuoka Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot assisted distal gastrectomy

Arm Description

patients who received robot assisted distal gastrectomy

Outcomes

Primary Outcome Measures

The Incidence of Post-operative Intra-abdominal Infectious Complications

Secondary Outcome Measures

Overall Survival
Relapse Free Survival
Completion Rate of Robot Assisted Surgery
Incidence of Adverse Events

Full Information

First Posted
December 30, 2011
Last Updated
October 12, 2016
Sponsor
Shizuoka Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01504997
Brief Title
Phase II Study for Robot Assisted Distal Gastrectomy
Acronym
RADGphaseII
Official Title
A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shizuoka Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
DaVinci, Robot assisted surgery, Gastrectomy, Safety, Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot assisted distal gastrectomy
Arm Type
Experimental
Arm Description
patients who received robot assisted distal gastrectomy
Intervention Type
Device
Intervention Name(s)
Robot assisted distal gastrectomy (DaVinci)
Other Intervention Name(s)
DaVinci
Intervention Description
patients who received robot assisted distal gastrectomy
Primary Outcome Measure Information:
Title
The Incidence of Post-operative Intra-abdominal Infectious Complications
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
5 years
Title
Relapse Free Survival
Time Frame
5 years
Title
Completion Rate of Robot Assisted Surgery
Time Frame
During the surgery, an expected average of 5 hours
Title
Incidence of Adverse Events
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy specimen from the primary lesion shows adenocarcinoma Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography Endoscopic submucosal dissection is not indicated Tumor was located within lower two thirds of stomach Not having duodenal invasion Eastern clinical oncology group performance status is 0 or 1 Body mass index is lower than 30 No prior laparotomy No prior chemotherapy or radiation including those for other cancers Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl Exclusion Criteria: Having other active cancers Possibly pregnant, or breast feeding woman with psychiatric disorder Receiving steroids With Acute myocardial infarction in 6 months or with unstable angina With uncontrolled hypertension With uncontrolled diabetes mellitus With pulmonary disease which require continuous oxygen therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masanori Terashima, M.D., Ph.D.
Organizational Affiliation
Division of Gastric Surgery, Shizuoka Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-0934
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Phase II Study for Robot Assisted Distal Gastrectomy

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