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 |