A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or
oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and
fluoropyrimidine.
This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be
enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be
'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening
period, a screening period and a treatment period. A fresh tumour biopsy sample will be
obtained during the prescreening period for gene expression profiling.
As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the
trial.
Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy
performed prior to 1st cycle.
Phase:
Phase 2
Details
Lead Sponsor:
National University Hospital, Singapore
Collaborators:
National Cancer Centre, Singapore Yonsei University