Gastric Cancer Survival Without Chemotherapy

NCT05125614 | Completed

• 1 other identifier: apzzap2
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Adjuvant chemotherapy; Overall survival; Nomogram; Prediction

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival of the patients

  June-01-2021

Study Arms (2)

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

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

Interventions

No adjuvant chemotherapy OTHER

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

Developement set; Validation set

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead

Study Sites (1)

Saint Vincent Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Ki Bum Park, M.D.

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 18, 2021
• Study Start: May 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 2022, 3 years

Locations

KR (1)