|Title of study||
Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?
4.3, 5 January 2021 (Dutch Version)
STAR-TREC fase III
UK: Mr Simon Bach National Surgical Lead for the UK University of Birmingham, UK NL:Professor Hans De Wilt National Surgical Lead for The Netherlands Radboud University, Nijmegen Medical Centre, Netherlands
Dr M. Berbée
The phase III component will evaluate two contrasting organ preservation strategies (either long-course chemoradiotherapy or short-course radiotherapy) for the treatment of early stage rectal cancer in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL). The phase III study will also include a standard TME radical surgery (non- randomised) comparator arm encompassing reconstructive (low anterior resection) and non-reconstructive (abdominoperineal excision, low Hartmann’s procedure) approaches.
The proportion of patients with successful organ preservation at 30 months from the start date of (chemo)radiotherapy. Organ preservation is considered to have failed (a) if the rectum is removed; (b) if the patient develops unequivocal locoregional cancer recurrence or (c) if the patient has a stoma.