Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality
and major short and long term morbidity induced by rectal excision justifies new treatments.
Local excision is a conservative alternative approach associated with low mortality and
morbidity. The purpose of this prospective randomised multicenter study is to compare local
vs rectal excision in good responders after radiochemotherapy for low rectal cancer.
Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm,
received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with
concomitant chemotherapy consist of at least, one fluoropyrimidine.
Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal
excision, 6-8 weeks after treatment. In case of not confirmed pathological response
following local excision, complementary rectal excision is required.
Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up
includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision)
every 4 months for 2 years, then every 6 months for 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after
Eric RULLIER, Pr.
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)