Through an observational study, the efficacy and safety of preoperative chemoradiotherapy followed by surgery in patients with recurrent rectal cancer were assessed. The primary population included patients with (potentially) resectable locally recurrent rectal cancer, excluding those with distant metastases. The study design was a prospective, open-label, single-arm observational study. The primary endpoint was the pCR (pathological complete response) rate, while secondary endpoints included R0 resection rate, local recurrence-free survival, overall survival, and safety.
Study Type
OBSERVATIONAL
Enrollment
100
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
pathologic complete response
The resected tumor tissue and regional lymph nodes were pathologically assessed, revealing no residual tumor cells. The tumor lesions had completely disappeared, and no new lesions were detected.
Time frame: up to 26 weeks
R0 rates
The complete tumor resection rate is defined as the absence of cancer cells at the resection margins under a microscope, with no visible or microscopic residual cancer cells, indicating that the lesion has been entirely removed.
Time frame: up to 26 weeks
progression-free survival
The interval between the start of enrollment and local recurrence, progression of local recurrence, distant metastasis, or death.
Time frame: 5 years
overall survival
The interval between the start of enrollment and death.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.