Prospectively Investigate the effectiveness and safety of neoadjuvant cetuximab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS wild-type locally advanced rectal cancer
Study Type
OBSERVATIONAL
Enrollment
51
cetuximab 500mg/m2 d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles
25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPathological response rate
Tumor Regression Grade 0-1
Time frame: two weeks after surgery
Pathological complete response rate
Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)
Time frame: two weeks after surgery
2-year local control rate
Refers to the probability of not finding local recurrence of tumor within 2 years,including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit.
Time frame: 2 years after enrollment
2-year metastasis-free rate 2-year distant metastasis free rate
Refers to the probability of no distant metastasis within 2 years
Time frame: 2 years after enrollment
Overall survival
Refers to the time from the start of treatment to death due to any cause.
Time frame: 2 years after enrollment
disease-free survival
Refers to the time from the start of treatment to recurrence.
Time frame: 2 years after enrollment
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