Total Neoadjuvant Therapy for lymph node-positive adenocarcinoma of the OESophagus and oesophagogastric junction: TNT-OES-2 trial

oesophagogastric junction cancer, oesophageal cancer

• The progression-free survival defined as the time interval from randomization to the first event of local failure, regional failure, progression to metastatic disease or death

• Feasibility is defined as the proportion of patients that complete all 4 cycles of FLOT and all 5 chemotherapy cycles of CROSS, permitting dose reductions and delays, • Overall survival (OS), calculated from the date of randomization to the date of death due to any cause or, for patients alive at trial closure, date of last follow-up, • The number of patients with any major systemic therapy related toxicity, defined as grade ≥ 3 according to the Common Terminology Criteria for Adverse Events (CTCAE ) version 5.0), up to one month after the last administration of TNT (37), • The rate of any grade mucositis, up to one month after the last administration of TNT, • The number of patients requiring dose reductions or treatment delays during CROSS and FLOT, • The number of patients requiring G-CSF as primary or secondary prophylaxis, • The number of serious adverse events (SAEs), up to one month after last administration of TNT, • Surgical morbidity (Clavien-Dindo ≥3) and mortality (30-day, 90-day and/or in-hospital mortality), monitored within the Dutch upper gastrointestinal cancer audit (DUCA) surgical complications registry (38), • The proportion of resections that are radical (R0), microscopically irradical (R1) and macroscopically irradical (R2), • The proportion of patients that is unable to undergo oesophagectomy due to clinical deterioration, • The proportion of patients that choose for an active surveillance strategy instead of surgery after CRE-2, • Clinical complete response (cCR) rate is defined as the percentage of patients without residual locoregional disease or distant metastases at CRE-2, • Pathological complete response (pCR) rate in those who underwent an oesophagectomy is defined as ypT0N0, • Major pathological response in those who underwent oesophagectomy, defined as Mandard 1-2 (39), • The distant dissemination rate, defined as the proportion of metastases at 12 weeks after completion of TNT FLOT-CROSS or TNT CROSS-FLOT, detected by 18F-FDG, • Health-related quality of life (HRQoL), as measured by QoL questionnaires: EORTC QLQ-OG25 and EORTC-C30 (40, 41)

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Netherlands