Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy

NCT06277453 | Active Not Recruiting

• 1 other identifier: 2024KY010
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival

  3-year overall survival

  3 years

Study Arms (2)

AC ≥5

Patients with lymph node-negative gastric cancer who received neoadjuvant chemotherapy and underwent at least five cycles of adjuvant chemotherapy (AC ≥5) after surgery

Other: surgery

AC <5

Patients with lymph node-negative gastric cancer who received neoadjuvant chemotherapy and underwent at less five cycles of adjuvant chemotherapy (AC \<5) after surgery

Other: surgery

Interventions

surgery OTHER

radical gastric cancer surgery (R0) and D2 lymph node dissection

AC <5; AC ≥5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with node-negative gastric cancer following neoadjuvant chemotherapy

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Gastric Surgery， Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Chang-Ming Huang

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fujian Medical University Union Hospital

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: January 1, 2023
• Primary Completion: August 25, 2023
• Study Completion: September 30, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)