To investigate whether intraoperative intraportal chemotherapy combined with adjuvant chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative colorectal cancer resection compared with adjuvant chemotherapy alone. This is a prospective, blind (doctors who done outcome measures were masked), multi-center, 2-arm randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
700
IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
Zhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGdisease-free survival
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause.
Time frame: up to 5 year
overall survival
OS was measured from the date of randomization to the date of death from any cause.
Time frame: 3 year and 5 year
metastasis-free survival
MFS was defined as the time from randomization to metastasis if metastasis was the first event.
Time frame: 3 year and 5 year
adverse events of Chemotherapy and IPC
toxicity (using NCI CTC 3.0) compared with mFOLFOX6 alone.
Time frame: 6 months
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