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

February 19, 2024 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy: Multicenter Cohort Study

To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Department of Gastric Surgery， Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with node-negative gastric cancer following neoadjuvant chemotherapy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
radical gastric cancer surgery (R0) and D2 lymph node dissection
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
radical gastric cancer surgery (R0) and D2 lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival
Time Frame: 3 years
3-year overall survival
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Principal Investigator: Chang-Ming Huang, Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

August 25, 2023

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024KY010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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