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RECRUITING
NCT03125343
NA

Watch and Wait as Treatment for Patients With Rectal Cancer

Sponsor: Sahlgrenska University Hospital

View on ClinicalTrials.gov

Summary

A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included.

Official title: A Multicenter Prospective National Cohort Study for Patients With Advanced Rectal Cancer - is it Possible to Induce Remission and Avoid Surgery - Watch and Wait?

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2017-01

Completion Date

2028-12

Last Updated

2023-11-07

Healthy Volunteers

No

Interventions

PROCEDURE

endoscopy

Continuous follow-up. All patients with complete response will be followed for ten years. Details from the follow-up schedule will be registered in clinical record forms including information on the endoscopic findings, MRI findings and digital examination. They will be followed ever third month for the first two years as follows: * PET-CT is optional, but can be performed at inclusion * Pelvic MRI including diffusion weighted imaging according to appendix C. * Clinical examination * Endoscopy (flexible sigmoidoskopy) with photodocumentation * CEA After two years the patients will be followed every six month with: * Pelvic MRI including diffusion weighted imaging according to appendix as at baseline * Clinical examination * Endoscopy with photodocumentation * CEA

PROCEDURE

Surgery

Surgery according to recommendations from the multidisciplinary group in patients that prefer surgery to a watch and wait strategy

DEVICE

MRI

Locations (2)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, Sweden

Karolinska Institutet

Stockholm, Sweden