A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study

What this Trial Is About

Researchers are investigating an active surveillance approach after neoadjuvant chemoradiotherapy for locally advanced oesophageal cancer in the SANO-2 study. This prospective cohort study follows the original SANO trial, focusing on monitoring safety and effectiveness of delaying surgery until cancer regrowth is detected. The study aims to provide an alternative treatment option while awaiting long-term results of the SANO trial, responding to patient interest and the Dutch patient federation's support for active surveillance in a controlled setting. Participants receive active surveillance after completing neoadjuvant chemoradiotherapy and showing complete clinical response (cCR). Two clinical response evaluations (CREs) are performed: the first at 5-6 weeks including endoscopy with biopsies, and the second at 10-12 weeks including PET-CT, endoscopy with biopsies, endoscopic ultrasonography, and fine-needle aspiration if lymph nodes are suspected. Surgery is offered if cancer is detected or if regrowth is suspected without distant metastases. Safety monitoring includes stopping rules that, if met, will halt further inclusion and offer surgical resection. During the study, patients undergo regular clinical assessments including imaging, biopsies, and endoscopies to detect cancer regrowth. Researchers measure safety by counting adverse events up to two years after procedure or surgery. They also evaluate relapse rates, survival outcomes, decision-making preferences, and patient feelings such as fear of recurrence and regret about treatment choices. The study follows participants for at least two years to observe outcomes and monitor adherence to diagnostic procedures and protocols.

Surgery As Needed for Oesophageal Cancer - 2