Rectal Cancer Clinical Trial
Official title:
A Randomized Controlled Clinical Trial to Investigate the Effects of Transanal Local Excision Following Radiotherapy for the Treatment of Ultra-low T2N0M0 Rectal Cancer
A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision，transanal local excision following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer
Rectal cancer is one of the most common malignancy worldwide. Currently, surgery is the main
treatment for stage I rectal cancer, which has good therapeutic effect. For ultra-low rectal
cancer, transanal local excision (TLE) has many advantages over total mesorectal excision
(TME), such as less trauma, shorter hospitalization time, lower incidence of complications,
protection of sexual function and protection of anal function. At present, transanal local
excision has become the recommended operation for the T1N0M0 rectal cancer. However, the risk
of lymph node metastasis still occurs in stage I tumors, especially in stage T2 tumors, the
lymph node metastasis rate can reach 12% - 29% according to the literature. Salvage TME or
chemoradiotherapy should be considered for the presence of positive margin of incision,
lymphatic/vascular invasion and poor histological differentiation after transanal local
excision. At present, the investigators have consulted a large number of literatures and
found that TEM is still lack of sufficient evidence in the treatment of T2N0M0 ultra-low
rectal cancer. Some studies believed that local excision combined with adjuvant therapy is
safe and reliable, but the evidence is not enough. For ultra-low T2N0M0 rectal cancer, more
studies need to be carried out to provide guidance for clinical treatment.
In this study, eligible patients will be randomly allocated to operative operation for rectal
cancer either by simple TLE，TLE following radiotherapy or TME. 5-years disease free survival
rate, 5-years overall survival rate，local recurrence rate and postoperative quality of life
will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for
3 years postoperatively to study the long term effects.
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