Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Four points around the tumor site and center of the tumor site full-thickness Biopsy
diginal examination, endoscopy test, rectal MRI, and serum CEA level
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
RECRUITINGClinical Complete Response rate
Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer
Time frame: 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer
pathological complete remission
No tumor cell found in surgical specimens
Time frame: 2 weeks after patients received radical operation
Disease Free Survival
no tumor regrowth or recurrence or metastasis found
Time frame: 5 years after operation or "watch and wait" approach
Overall Survival
survive during following
Time frame: 5 years after operation or "watch and wait" approach
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