Status:
COMPLETED
A Validation Study of Relationships Among Genomic Gene Expression Profile, Prognosis and Prediction of Adjuvant Chemotherapy Benefit With Capecitabine and Oxaliplatin in Gastric Cancer Stage II and III (6th AJCC) Patients After D2 Surgery (CLASSIC)
Lead Sponsor:
Yonsei University
Conditions:
Stage II-III Gastric Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- aged 18 years or older
- histologically confirmed, American Joint Committee on Cancer/Union Internationale Contre le Cancer (6th edition) 2 stage II (T2N1, T1N2, T3N0), IIIA (T3N1, T2N2, T4N0), or IIIB (T3N2) gastric adenocarcinoma with no evidence of metastatic disease
- previous D2 surgery with achieved R0 resection
- Karnofsky performance status of \>70%
- adequate renal function (creatinine clearance \>50 mL/min or serum creatinine ≤1·5 times the upper limit of normal), hepatic function (total bilirubin ≤1·5 times the upper limit of normal, aspartate or alanine aminotransferase ≤2·5 times the upper limit of normal), and hematological function (absolute neutrophil count ≥1·5 × 109/L or platelet count ≥100 × 109/L)
- adequate hepatic function
- formalin-fixed paraffin-embedded (FFPE) tumor blocks, pathologic reports, and clinical information were all available.
Exclusion
- chemotherapy, immunotherapy, or radiotherapy for GC prior to surgery
- no available FFPE tumor blocks
- insufficient RNA quality to be analyzed.
Key Trial Info
Start Date :
July 13 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 12 2017
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT03403296
Start Date
July 13 2016
End Date
July 12 2017
Last Update
January 18 2018
Active Locations (1)
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1
Department of Surgery, Yonsei University College of Medicine
Seoul, South Korea, 03722