Clinical trial NCT06673472: Comparison of Long-term Outcomes Between Upfront Surgery and Neoadjuvant Therapy Followed by Surgery in Patients with Node-Negative Gastric Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymph Node-negative
Gastric Cancer
Keywords: Gastric cancer
Neoadjuvant therapy
Long-term outcomes
Lymph node-negative
SEER database
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 1081
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

(1) 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.

Exclusion Criteria:

(1) 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.

Primary outcomes:
measure: survival
timeFrame: Within 3 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Chang-ming
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-Ming Huang
role: PRINCIPAL_INVESTIGATOR
References: