The main cause of recurrence after surgical treatment of colon cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. This randomized multicenter phase III trial is assessing whether preoperative chemotherapy improves oncologic outcomes of patients with locally advanced colon cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
708
4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy
12 cycles of postoperative FOLFOX chemotherapy
Chonnam National University Hwasun Hospital
Hwasun, Chonnam, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
The Catholic Univ. of Korea St. Vincent's Hospital
Suwon, South Korea
Relapse free survival after randomization
Time frame: 3 years after randomization
Overall survival
Time frame: 3 year after randomization
Radiological assessment of response to neoadjuvant treatment
Time frame: 6 months after surgery
Pathological assessment of response to neoadjuvant treatment
Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue
Time frame: 1 months after surgery
Surgical complication
Time frame: 60 days after surgery
Length of hospital stay
Time frame: 60 days after surgery
Quality of life (EORTC QLQ-C30)
QLQ (quality of life questionnaire)
Time frame: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Quality of life (EORTC QLQ-C38)
Time frame: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Toxicity of chemotherapy
Toxicity : incidence of chemotherapy-related adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) v4.0
Time frame: 1 year
Incidence of completion of chemotherapy
Time frame: 1 year
Accuracy of CT staging
Time frame: 1 year
Total cycles of perioperative chemotherapy
Time frame: 1 year
Pathological tumor stage
Colon cancer stage by AJCC 8th edition
Time frame: 1 month after surgery
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