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Completed

NCT Number: NCT05125614

Gastric Cancer Survival Without Chemotherapy

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.

Completed

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Vincent Hospital

Suwon, Gyeonggi-do, 16247, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall survival

    Time frame: June-01-2021

    Overall survival of the patients

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2021
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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