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Trial Title:
Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy
NCT ID:
NCT06277453
Condition:
Locally Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
surgery
Description:
radical gastric cancer surgery (R0) and D2 lymph node dissection
Arm group label:
AC <5
Arm group label:
AC ≥5
Summary:
To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific
patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy.
Detailed description:
We analyzed clinicopathological data from patients with lymph node-negative gastric
cancer who underwent neoadjuvant chemotherapy at four institutions between 2010 and 2020.
The 3-year OS was assessed using landmark analysis. Independent risk factors associated
with 3-year OS were identified using a Cox proportional hazards regression model.
Criteria for eligibility:
Study pop:
Patients with node-negative gastric cancer following neoadjuvant chemotherapy
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- (1) preoperative neoadjuvant chemotherapy; (2) primary gastric adenocarcinoma,
diagnosed by gastroscopic pathology findings before neoadjuvant chemotherapy in
complete pathological remission (pCR) cases or via postoperative pathology findings
in all other instances; (3) absence of distant metastases in the liver, lungs, or
abdominal cavity, as confirmed by preoperative chest radiography or chest computed
tomography (CT), abdominal ultrasonography, abdominal CT, and other imaging; (4)
radical gastric cancer surgery (R0) and D2 lymph node dissection; and (5)
postoperative pathologic verification of no lymph node metastasis (i.e., lymph
node-negative).
Exclusion Criteria:
- (1) preoperative radiotherapy or radiochemotherapy, (2) discovery of distant
metastases preoperatively or intraoperatively, (3) coexistence of other malignant
tumors, (4) residual gastric cancer, and (5) perioperative patient mortality.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastric Surgery， Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Country:
China
Start date:
January 1, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Fujian Medical University
Agency class:
Other
Source:
Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277453
