NORWAIT: “Watch and Wait” in patients with complete clinical response (cCR) after neo-adjuvant chemoradiotherapy for primary locally advanced rectal cancer

Trial Overview

Acronym	NORWAIT
Number	n/a
Protocol Link	https://docs.wixstatic.com/ugd/758a26_bac251bb152348198d396e09a95d6aaf.pdf
Public Trial Registry Link	https://clinicaltrials.gov/ct2/show/NCT03402477
Status	Open/recruiting
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Neoadjuvant

Trial Description

National prospective cohort study aiming to reveal the true complete response rate in patients with clinical complete response after neo-adjuvant treatment for advanced rectal cancer in Norway. All patients who received neo-adjuvant treatment for rectal cancer according to Norwegian national guidelines who have a clinical complete response after 6-12 weeks are eligible for inclusion. By linking data of the NORWAIT trial to data from the Cancer Registry of Norway/Norwegian Colorectal Cancer Regis

Chief Investigator

Hartwig Kørner
MD, PhD, Professor of Surgery

Profile Link

Lead Centre

Stavanger University Hospital
Gerd-Ragna-Bloch gate 8
Stavanger
4011
Norway

Website

Additional Information

Full Research Summary

Objective:	To study the Watch&Wait approach in patients with clinical complete response after neo-adjuvant treatment for rectal cancer in a national cohort of patients in Norway
Aim:	To reveal the true rate of complete response in a national cohort of patients with rectal cancer who underwent neo-adjuvant treatment for advanced rectal cancer according to Norwegian treatment guidelines
Methods:	Prospective national cohort. Data from patients included in the NORWAIT trial will be linked to data from the Cancer Registry of Norway/Norwegian Colorectal Cancer Registry. Thus, it will be possible to account for all patients treated for rectal cancer during the study period in Norway, including those who had a ypT0 after surgery for rectal cancer to those who did not want to participate in the study or declined W&W for any reasons.
Reason for International Trial:	The trial is a national cohort study; however, the results will possible to compare with international figures