Gastric Cancer Survival Without Chemotherapy

November 17, 2021 updated by: Ki Bum Park, Saint Vincent's Hospital, Korea

Development of a Staging System and Survival Prediction Model for Advanced Gastric Cancer Patients Without Adjuvant Treatment After Curative Gastrectomy

This study is observational study to analyze the actual overall survival of the patients who did not receive adjuvant chemotherapy after curative gastrectomy for gastric cancer.

The investigators developed prediction model for the overall survival of these patients and validated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adjuvant chemotherapy (AC) after curative gastrectomy is the standard treatment for patients with locally advanced gastric adenocarcinoma in East Asia; however, for various reasons, some patients do not receive this treatment. The aim of this study was to develop a system that reflects the survival rate of patients without AC. A survival prediction model was developed based on the modified staging system and risk factors for overall survival (OS), which were examined using the Cox proportional hazards regression model. The model was validated for the power of prediction and discrimination, compared with the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition; it was externally validated using an independent dataset. the newly developed survival prediction model improves the accuracy of OS prediction for stage II and III gastric cancer patients without AC after curative gastrectomy.

Study Type

Observational

Enrollment (Actual)

342

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

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Saint Vincent 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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Informed consent was not required because of the retrospective nature of the study. For the development set, the database of the Gastric cancer center at Seoul St. Mary's hospital was reviewed between January 2009 and December 2016. The inclusion criteria were: histologically confirmed primary gastric adenocarcinoma, curative R0 resection with D2 lymph node dissection, and pathologic stage II or III. Exclusion criteria were: neoadjuvant or AC treatment, follow-up loss or death within 30 days of surgery, completion of total gastrectomy, and other malignancy within 5 years before gastrectomy. Finally, 185 patients with locally advanced GC, all of whom underwent curative gastrectomy without chemotherapy, were included in the development set. The validation set consisted of patients who satisfied the above inclusion and exclusion criteria from St. Vincent's hospital in the same period. Finally, 157 patients were included in the validation set

Description

Inclusion Criteria:

  • histologically confirmed primary gastric adenocarcinoma
  • curative R0 resection with D2 lymph node dissection
  • pathologic stage II or III gastric cancer

Exclusion Criteria:

  • Patients who received neoadjuvant or AC treatment
  • follow-up loss or death within 30 days of surgery
  • completion of total gastrectomy
  • other malignancy within 5 years before gastrectomy

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Developement set
Gastric cancer patients who did not receive adjuvant chemotherapy after curative gastrectomy from 2009 to 2016 at Seoul St.Mary's Hospital
Other: No adjuvant chemotherapy
There is no intervention differences between 2 groups. We analyzed the data of the patients who did not receive adjuvant chemotherapy.
Validation set
Gastric cancer patients who did not receive adjuvant chemotherapy after curative gastrectomy from 2009 to 2016 at St.Vincent''s Hospital
Other: No adjuvant chemotherapy
There is no intervention differences between 2 groups. We analyzed the data of the patients who did not receive adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: June-01-2021
Overall survival of the patients
June-01-2021

Collaborators and Investigators

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

Sponsor

Saint Vincent's Hospital, Korea

Investigators

  • Principal Investigator: Ki Bum Park, M.D., St Vincent's 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)

May 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 17, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • apzzap2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data that support the findings of this study are available from the corresponding author upon reasonable request.

IPD Sharing Time Frame

January 2022, 3 years

IPD Sharing Supporting Information Type

  • Study Protocol

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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