Early Gastric CancerPhase 2RADGphaseIINCT01504997
Phase II Study for Robot Assisted Distal Gastrectomy
A Phase 2 study testing Robot assisted distal gastrectomy (DaVinci) in people with Early Gastric Cancer, run by Shizuoka Cancer Center at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Robot assisted distal gastrectomy (DaVinci)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2011to Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer
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.
- Conditions
- Early Gastric Cancer
- Being tested
- Robot assisted distal gastrectomy (DaVinci)
- Keywords
- DaVinci, Robot assisted surgery, Gastrectomy, Safety, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted distal gastrectomy (DaVinci)Device
Also called DaVinci
patients who received robot assisted distal gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted distal gastrectomy | Experimental | patients who received robot assisted distal gastrectomy Receives: Device: Robot assisted distal gastrectomy (DaVinci) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Post-operative Intra-abdominal Infectious Complications
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes (4)
Overall Survival
Measured: 5 years
Relapse Free Survival
Measured: 5 years
Completion Rate of Robot Assisted Surgery
Measured: During the surgery, an expected average of 5 hours
Incidence of Adverse Events
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shizuoka Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masanori Terashima, Shizuoka Cancer Center
- Investigators
- Masanori Terashima, M.D., Ph.D., Principal investigator, Division of Gastric Surgery, Shizuoka Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504997
- Sponsor's protocol ID
- DaVinci_SCC
- Other IDs
- UMIN000006910
- Acronym
- RADGphaseII
- Status last verified
- Oct 2016
- First submitted
- 30 Dec 2011
- Last updated
- 29 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer
- ClinicalTrials.gov ID
- NCT01504997
- Acronym / sponsor ID
- RADGphaseII / DaVinci_SCC
- Conditions
- Early Gastric Cancer
- Keywords
- DaVinci, Robot assisted surgery, Gastrectomy, Safety, Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Shizuoka Cancer CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Posted 25 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot assisted distal gastrectomy | Experimental | Device: Robot assisted distal gastrectomy (DaVinci)patients who received robot assisted distal gastrectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot assisted distal gastrectomy (DaVinci)Also: DaVincipatients who received robot assisted distal gastrectomy | Device | Robot assisted distal gastrectomy |
Primary outcome
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
4 secondary outcomes
Overall Survival
Time frame: 5 years
Relapse Free Survival
Time frame: 5 years
Completion Rate of Robot Assisted Surgery
Time frame: During the surgery, an expected average of 5 hours
Incidence of Adverse Events
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
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The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masanori Terashima, M.D., Ph.D. principal investigator
Division of Gastric Surgery, Shizuoka Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robot assisted distal gastrectomy (DaVinci) in people with Early Gastric Cancer, run by Shizuoka Cancer Center at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.