This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1 oxaliplatin 85 mg/m² iv continue for 2 hours, D1 leucovorin 400 mg/m² iv continue for 2 hours, D1 5-FU 2400\~3200 mg/m² cont. inf. 48h, D1 repeat every 2 weeks (Q2W)
oxaliplatin 130 mg/m2 iv continue for 2 hours, D1 capecitabine 1000mg/m2/d PO Bid, once every morning and evening D1-14 repeat every 3 weeks (Q3W)
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Shanghai, Shanghai Municipality, China
RECRUITING3-year disease free survival
Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first. Compare 3-year disease free survival in patients with locally advanced rectal cancer treated with either FOLFOXIRI or CapeOX neoadjuvant chemotherapy.
Time frame: 3 years
pathologic complete response rate
Defined as the ratio of patients with pathologic TRG 0
Time frame: 1 year
major pathologic response rate
Defined as the ratio of patients with pathologic TRG 0 or 1
Time frame: 1 year
objective response rate
Defined as the ratio of patients with MRI-TRG 1, 2 or 3
Time frame: 1 year
local recurrence rate
Defined as the ratio of patients with local recurrence within 3 years.
Time frame: 3 years
overall survival
Defined as the length of time from randomization date until the date of death from any cause.
Time frame: 5 years
quality of life as assessed by EORTC QOL-C30
Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-C30 version 3
Time frame: 3 years
quality of life as assessed by EORTC QOL-CR29
Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-CR29.
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Time frame: 3 years
adverse event
Number of patients with adverse events and severity according to NCI CTC 5.0 after neoadjuvant chemotherapy.
Time frame: 1 year