Highlights of the NCCN Oncology Research Program

2020 The Journal of the National Comprehensive Cancer Network  
This is an open-label, multicenter, phase II study of trifluridine/tipiracil (FTD/TPI) administered with oxaliplatin before chemoradiation in patients with adenocarcinoma of the esophagus or gastroesophageal junction (GEJ). Patients meeting inclusion criteria will receive 3 cycles of FTD/TPI (35 mg/m 2 twice daily) and oxaliplatin (85 mg/m 2 ) before undergoing concurrent chemoradiation (standard-of-care radiation dose of 5,040 cGy will be used at all participating study sites) with carboplatin
more » ... (area under the curve 2) and paclitaxel (50 mg/m 2 ) for 6 weeks, followed by surgery. FTD/TPI will be self-administered (in tablet form) twice daily by study participants and documented in the provided drug diary. In this study, circulating tumor DNA (ctDNA) levels will be collected at 5 different time points: at diagnosis, after completion of induction chemotherapy, after completion of chemoradiation, after surgery, and at the time of disease recurrence, if this occurs. The aim is to correlate the ctDNA level with disease recurrence and metabolic response on PET/CT. Accrual is expected to take 24 months (N545) with an additional 12 months of follow-up on study. After completion of 1 year of on-study follow-up, patients will be followed (monitored for survival status) as per standard of care: year 1 through year 2, every 3 to 6 months, every 6 to 12 months for 3 to 5 years, and then annually until disease progression or death, whichever occurs first. Estimated time frame for analysis of the primary endpoint is approximately 3 years after study commencement.
doi:10.6004/jnccn.2020.0014 fatcat:etsau6bzrffdfkp3zbaddxj65i