The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer
Local excision must involve all tissue invaded on pretreatment examination. For this reason,
4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment.
Next, the long-course radiochemotherapy or short-course radiotherapy is randomly allocated.
After 6 weeks interval, the full thickness local excision should be carried out with 1 cm
margin. Patients with good pathological response (complete response or downstaging to ypT1
disease)are followed up. Conversion to open surgery is offered to patients with poor
pathological response (ypT2-3 or positive margin). Close follow-up is carried out in order
to detect an early local recurrence either in a bowel wall or in mesorectal lymph nodes.
Rescue surgery is offered in patients with local recurrence.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.
Surrogate endpoint available immediatly after surgery.
Krzysztof Bujko, Prof.
Roentgena 5, 02-781 Warsaw, Poland
Poland: Ministry of Science and Higher Education