Rectal Cancer Clinical Trial
Official title:
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in
reporting the proportion of patients achieving clinical complete response (cCR) after
routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection.
This proportion in population-based level is poorly defined. In addition, predictive factors
for cCR are also poorly defined. It is known that cCR response is observed often in small
tumours. However, cCR proportion in large cancers has not been sufficiently evaluated. For
example, even though pathological complete response (pCR) does occur in large fixed cancer,
it is unknown whether cCR does also occur because persistent fibrous stroma may mimic
residual cancer in all of such cases.
This is a prospective observational population-based cohort study on low rectal cancer to
answer the question of how often clinical or near-clinical tumour response occur after
routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour
characteristics. The additional question was how often pCR occur in relation to the
pre-treatment tumour characteristics in the patients managed by total mesorectal excision
because of persistent tumour after radiotherapy. The additional aim was the implementation of
watch-and-wait strategy or full-thickness local excision (as an option instead of total
mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective
study. In the patients managed by organ preservation, the secondary outcome measures were: i)
local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3
years and overall survival at 5 years, iv) anorectal function.
n/a
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