1. A phase Ib feasibility trial of response adapted neoadjuvant therapy in gastric cancer (RANT-GC)
- Author
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Dayyani, Farshid, Smith, Brian R, Nguyen, Ninh T, Daly, Shaun, Hinojosa, Marcelo W, Seyedin, Steven N, Kuo, Jeffrey, Samarasena, Jason B, Lee, John G, Taylor, Thomas H, Cho, May T, and Senthil, Maheswari
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Digestive Diseases ,Cancer ,Clinical Trials and Supportive Activities ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Antineoplastic Combined Chemotherapy Protocols ,Chemotherapy ,Adjuvant ,Clinical Trials ,Phase I as Topic ,Feasibility Studies ,Gastrectomy ,Humans ,Neoadjuvant Therapy ,Neoplasm Staging ,Prospective Studies ,Stomach Neoplasms ,ctDNA ,gastrectomy ,gastric cancer ,neoadjuvant chemotherapy ,Oncology & Carcinogenesis ,Oncology and carcinogenesis - Abstract
Current guidelines recommend neoadjuvant (NAC) and/or adjuvant chemotherapy for locally advanced gastric cancers (LAGCs). However, the choice and duration of NAC regimen is standardized, rather than personalized to biologic response, despite the availability of several different classes of agents for the treatment of gastric cancer (GC). The current trial will use a tumor-informed ctDNA assay (Signatera™) and monitor response to NAC. Based on ctDNA kinetics, the treatment regimen is modified. This is a prospective single center, single-arm, open-label study in clinical stage IB-III GC. ctDNA is measured at baseline and repeated every 8 weeks. Imaging is performed at the same intervals. The primary end point is the feasibility of this approach, defined as percentage of patients completing gastrectomy.
- Published
- 2022