Acronym
TESAR
Name of the study
A Multi-centre randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer
Researchers and contact information
Principal Investigators:
Dr. J.B. Tuynman
Amsterdam UMC
Location VU Medical Center
De Boelelaan 1117
1007 MB Amsterdam
Location ZH 7F 20
Trial coordinator:
Lisanne J.H. Smits
www.tesartrial.nl
Summary study
In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomised between adjuvant chemo-radiotherapy limited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non-inferiority study with a total sample size of 302 patients .
Intervention
Arm A
Completion TME
Arm B
Adjuvant chemoradiotherapy (25x1.8 Gy + Capecitabine)