Stomach NeoplasmsNCT02902575
The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
A study testing Laparoscopic-assisted gastrectomy with D2 lymphadenectomy in people with Stomach Neoplasms, run by Fujian Medical University.
Trial summary
The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Laparoscopic-assisted gastrectomy with D2 lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or 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, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- History of other malignant disease within past five years
- History of unstable angina or myocardial infarction within past six months
Show all 11Show fewer
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
About this study
The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.
Read the detailed description
A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
- Conditions
- Stomach Neoplasms
- Being tested
- Laparoscopic-assisted gastrectomy with D2 lymphadenectomy
- Keywords
- Stomach Neoplasms, Laparoscopy, Advanced Gastric Cancer, Neoadjuvant Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic-assisted gastrectomy with D2 lymphadenectomyProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic-assisted Gastrectomy | Experimental | Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group Receives: Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classification system
Measured: 30 days
Secondary outcomes (32)
Pathological response
Pathological response grading was performed according to the Becker TRG system
Measured: 30 days
Radiological response
Radiological response and progression were assessed according to RECIST version 1.1
Measured: 30 days
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
Mortality
The early mortality are defined as the event observed within 30 days after surgery.
Measured: 30 days
Time to first ambulation
The data of postoperative recovery course
Measured: 10 days
Rates of combined organ resection
Combined organ resection performing by severe injury or abdominal adhesions
Measured: 1 day
The number of lymph node dissection
The number of lymph node dissection
Measured: 1 day
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months
Measured: 12 months
The daily highest body temperature
The daily highest body temperature before discharge
Measured: 7 days
Time to first flatus
Time to first flatus
Measured: 10 days
Time to first liquid diet
Time to first liquid diet
Measured: 10 days
Time to soft diet
Time to soft diet
Measured: 10 days
Scale the amount of abdominal drainage
Scale the amount of abdominal drainage
Measured: 10 days
Blood transfusion
Blood transfusion
Measured: 10 days
The number of positive lymph nodes
The number of positive lymph nodes
Measured: 1 days
Intraoperative lymph node dissection time
intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis.
Measured: 1 days
Intraoperative blood loss
Intraoperative blood loss
Measured: 1 days
Time of operation
Time of operation
Measured: 1 day
Intraoperative injury
Intraoperative injury
Measured: 1 days
The amount of use of titanium clip
The amount of use of titanium clip
Measured: 1 days
The rate of conversion to laparotomy
The rate of conversion to laparotomy
Measured: 1 days
The variation of albumin
The variation of albumin on postoperative 3, 6, 9 and 12 months
Measured: 12 month
The results of endoscopy
the results of endoscopy on postoperative 3 and 12 months
Measured: 12 month
The values of white blood cell count
the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded
Measured: 7 days
The values of hemoglobin
the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of C-reactive protein
the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of prealbumin
the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
Duration of hospital stay
Duration of hospital stay
Measured: 10 days
Late postoperative complication
The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th.
Measured: 36 months
Adverse events
Adverse events (AEs) of neoadjuvant chemotherapy were assessed at each visit per the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion31 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902575
- Sponsor's protocol ID
- FUGES-05
- Status last verified
- Jan 2021
- First submitted
- 11 Sep 2016
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02902575
- Acronym / sponsor ID
- FUGES-05
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, Laparoscopy, Advanced Gastric Cancer, Neoadjuvant Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.
Detailed description
A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic-assisted Gastrectomy | Experimental | Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomyLaparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group |
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 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
Key exclusion criteria (11 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- History of other malignant disease within past five years
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 |
|---|---|---|
| Laparoscopic-assisted gastrectomy with D2 lymphadenectomyAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy | Procedure or surgery | Laparoscopic-assisted Gastrectomy |
Primary outcome
Morbidity
Time frame: 30 days
The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classification system
32 secondary outcomes
Pathological response
Time frame: 30 days
Radiological response
Time frame: 30 days
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
Mortality
Time frame: 30 days
Time to first ambulation
Time frame: 10 days
Rates of combined organ resection
Time frame: 1 day
The number of lymph node dissection
Time frame: 1 day
The variation of weight
Time frame: 12 months
The daily highest body temperature
Time frame: 7 days
Time to first flatus
Time frame: 10 days
Time to first liquid diet
Time frame: 10 days
Time to soft diet
Time frame: 10 days
Scale the amount of abdominal drainage
Time frame: 10 days
Blood transfusion
Time frame: 10 days
The number of positive lymph nodes
Time frame: 1 days
Intraoperative lymph node dissection time
Time frame: 1 days
Intraoperative blood loss
Time frame: 1 days
Time of operation
Time frame: 1 day
Intraoperative injury
Time frame: 1 days
The amount of use of titanium clip
Time frame: 1 days
The rate of conversion to laparotomy
Time frame: 1 days
The variation of albumin
Time frame: 12 month
The results of endoscopy
Time frame: 12 month
The values of white blood cell count
Time frame: 7 days
The values of hemoglobin
Time frame: 7 days
The values of C-reactive protein
Time frame: 7 days
The values of prealbumin
Time frame: 7 days
Duration of hospital stay
Time frame: 10 days
Late postoperative complication
Time frame: 36 months
Adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic-assisted gastrectomy with D2 lymphadenectomy in people with Stomach Neoplasms, run by Fujian Medical University.
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 11 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: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Morbidity (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 26 Jan 2021.