Can We Save the Rectum by Watchful Waiting or TransAnal Surgery Following (chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

June 14, 2017

Primary Completion Date

April 30, 2027

Study Completion Date

August 31, 2028

Conditions
Adenocarcinoma of the Rectum
Interventions
PROCEDURE

Standard TME surgery

Total mesorectal excision

DRUG

Long course concurrent chemoradiation with capecitabine and radiotherapy

Capecitabine 825 mg/m² orally, b.i.d., on radiotherapy days. Radiotherapy: A dose of 50 Gy, applied to the primary tumour and surrounding mesorectum, in 25 fractions of 2 Gy, 5 days a week.

RADIATION

Short course radiotherapy

A dose of 25Gy, applied, to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week.

Trial Locations (5)

Unknown

University Hospital UZ Leuven, Leuven

Odense University Hospital, Odense

Radboud University medical center, Nijmegen

Region Stockholm, Onkologkliniken Södersjukhuset AB, Stockholm

B15 2TT

University of Birmingham, Birmingham

All Listed Sponsors
lead

University of Birmingham

OTHER