Watch and Wait as Treatment for Patients With Rectal Cancer

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2028

Conditions
Rectal Neoplasms
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

Trial Locations (2)

SE 416 85

RECRUITING

Dept. of Surgery, Sahlgrenska University Hospital/Ostra, Gothenburg

Unknown

RECRUITING

Karolinska Institutet, Stockholm

All Listed Sponsors
collaborator

Karolinska Institutet

OTHER

lead

Sahlgrenska University Hospital

OTHER