This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery (TEM) or endoscopic local resection for early low rectal cancer(cT 1-3N0M0).Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life (QoL) will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Radiotherapy:45Gy/25F+Boost 50Gy/25F. A total of 45 Gy, 25 fractions of 1.8 Gy, 5 fractions a week CapOx: Capecitabine 1000mg / m² po bid (1-14 days, 21 days a cycle) Oxaliplatin 130mg / m2 igtt(Day 1, 21 days a cycle) TEM or endoscopic local resection
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOrgan preservation rate at 3 years
Patients with a good pathological response(ypT 0-1 without neural vascular invasion)after neoadjuvant treatment followed by transanal endoscopic microsurgery(TEM)or endoscopic local resection will be offered an organ preservation strategy
Time frame: 3 years
Clinical complete response rate after neoadjuvant chemoradiotherapy
Define as complete withdrawal of rectal cancer after neoadjuvant radiotherapy and chemotherapy, and no distant metastasis in imaging examination, and no tumor residue in imaging examination and endoscopic biopsy
Time frame: 18 weeks
3-year local recurrence rate
Occurrence of local recurrence in patients with an organ preservation strategy
Time frame: 3 years
3-year distant metastases rate
Occurrence of distant metastases in patients with an organ preservation strategy
Time frame: 3 years
3-year Disease-free survival(DFS)rates
Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause
Time frame: 3 years
3-year overall survival(OS) rates
OS is defined as the time from enrollment to death due to any cause
Time frame: 3 years
Quality of life (EORTC-QLQ-C 30, psychological status)
Assess QLQ-C30 in patients with an organ preservation strategy
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Time frame: 20 weeks
5-year Disease-free survival(DFS)rates
Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause
Time frame: 5 years
5-year overall survival(OS) rates
OS is defined as the time from enrollment to death due to any cause
Time frame: 5 years