Gastric CancerNCT05537129
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
A study testing Total Gastrectomy in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Total Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
- age between 20 and 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
- scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
- written informed consent
- without preoperative chemotherapy and radiotherapy
Who cannot join
- clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
- history of chemotherapy, radiotherapy, immunotherapy or target therapy
- perigastric lymphnode≥3cm
- received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
- multiple primary tumors
- suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
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- patients need emergency operation with complication of gastric cancer
- adhesion due to the previous intraabdominal surgery
- need for combined organ resection due to aggression of gastric cancer of other disease,
- vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
- currently participating or participated in other clinical trials in the last 6 months
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, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Dazhi Xu, PHD，MD, 021-64175590, xudzh@shca.org.cn
About this study
Official title: A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
Read the detailed description
Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.
- Conditions
- Gastric Cancer
- Being tested
- Total Gastrectomy
- Keywords
- Gastric cancer, Laparoscopic Total Gastrectomy, Open Total 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 GastrectomyProcedure or surgery
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Total Gastrectomy | Experimental | Not described Receives: Procedure: Total Gastrectomy |
| Open Total Gastrectomy | Active comparator | Not described Receives: Procedure: Total Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year-DFS
3 year-disease free survival
Measured: 3 year
Secondary outcomes (2)
3 year-OS
3 year-overall survival
Measured: 3 year
morbidity and mortality rates
morbidity and mortality within 30 days following surgeries
Measured: 30 days following surgeries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 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 Fudan 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
- Investigators
- Dazhi Xu, PHD,MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537129
- Sponsor's protocol ID
- LOTGGC
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT05537129
- Acronym / sponsor ID
- LOTGGC
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 Sep 2022 (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.
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
Detailed description
Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Total Gastrectomy | Experimental | Procedure: Total Gastrectomy |
| Open Total Gastrectomy | Active comparator | Procedure: Total Gastrectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
- age between 20 and 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
- scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
Key exclusion criteria (11 listed)
- clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
- history of chemotherapy, radiotherapy, immunotherapy or target therapy
- perigastric lymphnode≥3cm
- received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
- multiple primary tumors
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 GastrectomyThe laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines. | Procedure or surgery | Laparoscopic Total Gastrectomy, Open Total Gastrectomy |
Primary outcome
3 year-DFS
Time frame: 3 year
3 year-disease free survival
2 secondary outcomes
3 year-OS
Time frame: 3 year
morbidity and mortality rates
Time frame: 30 days following surgeries
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 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Dazhi Xu, PHD,MD principal investigator
Fudan University
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 Gastrectomy in people with Gastric Cancer, run by Fudan 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 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: looking for participants now, as of the sponsor's last update on 13 Sep 2022. 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 Dazhi Xu, PHD, MD (021-64175590, xudzh@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year-DFS (time frame: 3 year). 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 13 Sep 2022.