An observational study in Gastric Cancer, sponsored by Saint Vincent's Hospital, Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Saint Vincent's Hospital, Korea · Observational
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 342 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
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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
Exclusion Criteria:
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
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.
Overall survival
Overall survival of the patients
Time frame: June-01-2021
Plan to share: Yes — The data that support the findings of this study are available from the corresponding author upon reasonable request.
Supporting information: Study protocol
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Saint Vincent's Hospital, Korea