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Gastric Cancer Survival Without Chemotherapy

NCT ID: NCT05125614

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

342 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Cancer

Keywords

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Gastric cancer Adjuvant chemotherapy Overall survival Nomogram Prediction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Developement set

Gastric cancer patients who did not receive adjuvant chemotherapy after curative gastrectomy from 2009 to 2016 at Seoul St.Mary's Hospital

No adjuvant chemotherapy

Intervention Type OTHER

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

No adjuvant chemotherapy

Intervention Type OTHER

There is no intervention differences between 2 groups. We analyzed the data of the patients who did not receive adjuvant chemotherapy.

Interventions

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No adjuvant chemotherapy

There is no intervention differences between 2 groups. We analyzed the data of the patients who did not receive adjuvant chemotherapy.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Vincent's Hospital, Korea

OTHER

Sponsor Role lead

Responsible Party

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Ki Bum Park

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ki Bum Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital

Locations

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Saint Vincent Hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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apzzap2

Identifier Type: -

Identifier Source: org_study_id