Gastric Cancer Survival Without Chemotherapy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125614
• Other study ID #: apzzap2
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: November 2021
• Source: Saint Vincent's Hospital, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Saint Vincent Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival of the patients	June-01-2021