Gastric CancerNCT04795063
Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
A study testing Total Robotic Distal Gastrectomy and Robotic-Assisted Distal Gastrectomy in people with Gastric Cancer and Robotic Gastrectomy, run by Fujian Medical University at 1 site in China.
Trial summary
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Robotic Gastrectomy
- What is being tested?
- Total Robotic Distal Gastrectomy and Robotic-Assisted Distal Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- American Society of Anesthesiology (ASA) class I to III
- Written informed consent
Who cannot join
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
- Gastric multiple primary carcinoma
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
Show all 14Show fewer
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- Forced expiratory volume in 1 second (FEV1)<50% of the predicted values
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Changming Huang, M.D., Ph.D., +86-133-6591-0253, hcmlr2002@163.com
Changming Huang, M.D., Ph.D.
About this study
Official title: Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).
Read the detailed description
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.
- Conditions
- Gastric Cancer, Robotic Gastrectomy
- Being tested
- Total Robotic Distal Gastrectomy, Robotic-Assisted Distal Gastrectomy
- Keywords
- Gastric Cancer, robotic assisted distal gastrectomy, total robotic distal gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Robotic Distal GastrectomyProcedure or surgery
All the surgical procedures are performed using the robot system.
Robotic-Assisted Distal GastrectomyProcedure or surgery
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
| Study group | Role | What they receive |
|---|---|---|
| Total Robotic Distal Gastrectomy | Experimental | After exploration and randomization, patients received total robotic distal gastrectomy Receives: Procedure: Total Robotic Distal Gastrectomy |
| Robotic-Assisted Distal Gastrectomy | Active comparator | After exploration and randomization, patients received robotic-assisted distal gastrectomy. Receives: Procedure: Robotic-Assisted Distal Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity rates
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Measured: 30 days
Secondary outcomes (10)
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months
3-year overall survival rate
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Measured: 36 months
intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Measured: 1 day
overall postoperative serious morbidity rates
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Measured: 30 days
Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
Measured: 1 day
postoperative recovery course
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: 30 days
postoperative nutritional status
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Measured: 3, 6, 9 and 12 months
inflammatory immune response
The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
Time of digestive tract reconstruction
From the beginning to the end of digestive tract reconstruction
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-ming Huang, MD, Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795063
- Sponsor's protocol ID
- FUGES-022
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT04795063
- Acronym / sponsor ID
- FUGES-022
- Conditions
- Gastric Cancer, Robotic Gastrectomy
- Keywords
- Gastric Cancer, robotic assisted distal gastrectomy, total robotic distal gastrectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).
Detailed description
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Robotic Distal Gastrectomy | Experimental | Procedure: Total Robotic Distal GastrectomyAfter exploration and randomization, patients received total robotic distal gastrectomy |
| Robotic-Assisted Distal Gastrectomy | Active comparator | Procedure: Robotic-Assisted Distal GastrectomyAfter exploration and randomization, patients received robotic-assisted distal gastrectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
Key exclusion criteria (14 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
- Gastric multiple primary carcinoma
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 |
|---|---|---|
| Total Robotic Distal GastrectomyAll the surgical procedures are performed using the robot system. | Procedure or surgery | Total Robotic Distal Gastrectomy |
| Robotic-Assisted Distal GastrectomyAfter finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal. | Procedure or surgery | Robotic-Assisted Distal Gastrectomy |
Primary outcome
Morbidity rates
Time frame: 30 days
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
10 secondary outcomes
3-year disease free survival rate
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
intraoperative morbidity rates
Time frame: 1 day
overall postoperative serious morbidity rates
Time frame: 30 days
Total Number of Retrieved Lymph Nodes
Time frame: 1 day
postoperative recovery course
Time frame: 30 days
postoperative nutritional status
Time frame: 3, 6, 9 and 12 months
inflammatory immune response
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
Time of digestive tract reconstruction
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Chang-ming Huang, MD study chair
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Robotic Distal Gastrectomy and Robotic-Assisted Distal Gastrectomy in people with Gastric Cancer and Robotic Gastrectomy, run by Fujian Medical University at 1 site in China.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 12 Mar 2021. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang-ming Huang, MD (+86-13805069676, hcmlr2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity rates (time frame: 30 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 12 Mar 2021.