Selected stage IV rectal cancer patients managed by the watch-and-wait approach after pelvic radiotherapy: a good alternative to total mesorectal excision surgery?

"CONFLICT OF INTEREST The authors have no conflicts of interest associated with this publication, and there has been no significant financial support for this work that could have influenced the outcomes."

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"In the Netherlands, since 2004, the majority of rectal cancer patients with a clinical (near‐)complete response of the rectal tumour following neoadjuvant (chemo)radiotherapy managed by a watch‐and‐wait approach have been registered in a trial registry (clinicaltrial.gov NCT00939666, NCT02278653 and NCT03426397). The three trial registries are approved by either the local institutional review board of Maastricht University Medical Centre or the medical ethics committee of the Netherlands Cancer Institute and are carried out in according with the Good Clinical Practice guidelines and the Declaration of Helsinki. Currently, 13 hospitals participate in the Dutch watch‐and‐wait registry, and clinicians can register patients with a clinical (near‐)complete response at their discretion. To ensure the quality of the registry, all patients were reassessed by the principal investigator before registration. Clinical data management was carried out by the Clinical Trials Office of the Netherlands Comprehensive Cancer Organisation and local investigators. All patients provided informed consent before registration. Clinical trial registration: clinicaltrial.gov NCT00939666, NCT02278653 and NCT03426397."