An observational study in Stage II-III Gastric Cancer, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Yonsei University · Observational
The purpose of this study is to validate a pre-defined single-patient classifier algorithm for predicting prognosis and benefit from adjuvant chemotherapy for patients who underwent D2 gastrectomy for stage II and III gastric cancer. This algorithm classifies gastric cancer into five groups according to its molecular characteristics based on RNA expression levels. The prognosis and response from adjuvant chemotherapy will be different according to prognostic and predictive clusters respectively based on these groups, thus this algorithm can identify as patients which will have benefit from adjuvant chemotherapy or which will not. Consequently, this algorithm can be translated into clinical practice to help doctors who decide the necessity of adjuvant chemotherapy after D2 gastrectomy for patients who had diagnosed stage II and III gastric cancer.
The purpose of this study is to validate a pre-defined single-patient classifier algorithm for predicting prognosis and benefit from adjuvant chemotherapy for patients who underwent D2 gastrectomy for stage II and III gastric cancer. This algorithm classifies gastric cancer into five groups according to its molecular characteristics based on RNA expression levels. The prognosis and response from adjuvant chemotherapy will be different according to prognostic and predictive clusters respectively based on these groups, thus this algorithm can identify as patients which will have benefit from adjuvant chemotherapy or which will not. Consequently, this algorithm can be translated into clinical practice to help doctors who decide the necessity of adjuvant chemotherapy after D2 gastrectomy for patients who had diagnosed stage II and III gastric cancer.
The cohort for this validation study is from patients who were enrolled the CLASSIC (Capecitabine and oxaliplatin Adjuvant Study in Stomach Cancer) trial, a randomized, open-label, multicenter, parallel-group, phase 3 study which compared the effect of adjuvant capecitabine plus oxaliplatin (XELOX) after D2 gastrectomy with surgery alone strategy. This trial was conducted between June, 2006 and June, 2009. The patient were from both surgery alone arm and surgery plus adjuvant XELOX arm, and have tumor blocks available for RNA extraction.
approximately 640 FFPE sample blocks from patients among 1035 enrolled in the CLASSIC trial (satisfied with below criteria)
Exclusion Criteria:
Patients with stage II-III GC who underwent D2 resection were randomized (1:1) after surgery to receive adjuvant capecitabine and oxaliplatin (eight three-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or observation alone. Assessment whether patients were disease free were done by abdominal CT or MRI and chest radiograph at regular intervals as planned by protocol.
Genetic: nProfiler I Stomach Cancer Assay Kit
qPCR by nProfiler I Stomach Cancer Assay Kit
Also known as: nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea)
overall survival(OS)
the time from randomization to the date of death from any cause.
Time frame: 5 years
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yonsei University