Lymph Node-negativeNCT06673472
Comparison of Long-term Outcomes Between Upfront Surgery and Neoadjuvant Therapy Followed by Surgery in Patients with Node-Negative Gastric Cancer
An observational study of Lymph Node-negative and Gastric Cancer, run by Chang-Ming Huang, Prof. at 1 site in China.
Trial summary
Patients with lymph node-negative gastric cancer, the prognosis of patients who underwent neoadjuvant therapy was poor than that of those who had upfront surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymph Node-negative, Gastric Cancer
- How many people
- 1,081 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 15 Sep 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We retrospectively analyzed the clinicopathological data of patients who underwent curative surgery for gastric cancer and were pathologically confirmed to have node-negative metastases between January 2010 and June 2021 at 8 institutions in China. Data from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2020) were used as the validation cohort. The patients were divided into two groups based on whether they received neoadjuvant therapy before surgery: the upfront surgery (UFS) group and the neoadjuvant therapy followed by surgery (NATS) group. A 1:1 propensity score matching analysis was employed to reduce the potential selection bias between the two groups.
Who may be able to join
- preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) underwent radical gastrectomy (R0) and D2 lymphadenectomy; (5) postoperative pathology confirmed no lymph node metastasis (i.e., lymph node-negative); and (6) follow-up for at least 3 years.
Who cannot join
- considered early-stage gastric cancer before surgery; (2) distant metastasis detected preoperatively or intraoperatively; (3) failure to achieve R0 resection and D2 lymphadenectomy during surgery; (4) concurrent diagnosis of other malignancies; (5) remnant gastric cancer; (6) death within 30 days postoperatively; and (7) incomplete baseline data or follow-up records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Long-term Outcomes Between Upfront Surgery and Neoadjuvant Therapy Followed by Surgery in Patients with Node-Negative Gastric Cancer: a Propensity Score Matched International Multicenter Study
Patients with lymph node-negative gastric cancer, the prognosis of patients who underwent neoadjuvant therapy was poor than that of those who had upfront surgery.
Read the detailed description
We retrospectively analyzed the clinicopathological data of patients who underwent curative surgery for gastric cancer and were pathologically confirmed to have node-negative metastases between January 2010 and June 2021 at 8 institutions in China. Data from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2020) were used as the validation cohort. The patients were divided into two groups based on whether they received neoadjuvant therapy before surgery: the upfront surgery (UFS) group and the neoadjuvant therapy followed by surgery (NATS) group. A 1:1 propensity score matching analysis was employed to reduce the potential selection bias between the two groups.
- Conditions
- Lymph Node-negative, Gastric Cancer
- Keywords
- Gastric cancer, Neoadjuvant therapy, Long-term outcomes, Lymph node-negative, SEER database
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
3-year overall survival , disease-specific survival，and disease-free survival
Measured: Within 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 May 2024
- Primary completion4 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node-negativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang-Ming Huang, Prof.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673472
- Sponsor's protocol ID
- 2024KY217
- Status last verified
- Sep 2024
- First submitted
- 2 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Long-term Outcomes Between Upfront Surgery and Neoadjuvant Therapy Followed by Surgery in Patients with Node-Negative Gastric Cancer: a Propensity Score Matched International Multicenter Study
- ClinicalTrials.gov ID
- NCT06673472
- Acronym / sponsor ID
- 2024KY217
- Conditions
- Lymph Node-negative, Gastric Cancer
- Keywords
- Gastric cancer, Neoadjuvant therapy, Long-term outcomes, Lymph node-negative, SEER database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,081 participants (actual)
- Lead sponsor
- Chang-Ming Huang, Prof.University, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 5 Nov 2024 (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.
Patients with lymph node-negative gastric cancer, the prognosis of patients who underwent neoadjuvant therapy was poor than that of those who had upfront surgery.
Detailed description
We retrospectively analyzed the clinicopathological data of patients who underwent curative surgery for gastric cancer and were pathologically confirmed to have node-negative metastases between January 2010 and June 2021 at 8 institutions in China. Data from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2020) were used as the validation cohort. The patients were divided into two groups based on whether they received neoadjuvant therapy before surgery: the upfront surgery (UFS) group and the neoadjuvant therapy followed by surgery (NATS) group. A 1:1 propensity score matching analysis was employed to reduce the potential selection bias between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively analyzed the clinicopathological data of patients who underwent curative surgery for gastric cancer and were pathologically confirmed to have node-negative metastases between January 2010 and June 2021 at 8 institutions in China. Data from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2020) were used as the validation cohort. The patients were divided into two groups based on whether they received neoadjuvant therapy before surgery: the upfront surgery (UFS) group and the neoadjuvant therapy followed by surgery (NATS) group. A 1:1 propensity score matching analysis was employed to reduce the potential selection bias between the two groups.
Key inclusion criteria (1 listed)
- preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) underwent radical gastrectomy (R0) and D2 lymphadenectomy; (5) postoperative pathology confirmed no lymph node metastasis (i.e., lymph node-negative); and (6) follow-up for at least 3 years.
Key exclusion criteria (1 listed)
- considered early-stage gastric cancer before surgery; (2) distant metastasis detected preoperatively or intraoperatively; (3) failure to achieve R0 resection and D2 lymphadenectomy during surgery; (4) concurrent diagnosis of other malignancies; (5) remnant gastric cancer; (6) death within 30 days postoperatively; and (7) incomplete baseline data or follow-up records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival
Time frame: Within 3 years after surgery
3-year overall survival , disease-specific survival，and disease-free survival
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 5 Nov 2024.
- 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. This study is not recruiting at the moment.
Chang-Ming Huang principal investigator
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?
An observational study of Lymph Node-negative and Gastric Cancer, run by Chang-Ming Huang, Prof. 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 1 inclusion and 1 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 5 Nov 2024. 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?
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?
survival (time frame: Within 3 years after surgery). 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 5 Nov 2024.