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A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer
Full description
For resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. However, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. Some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. Whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial.
In this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. For patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. Preoperative and postoperative chemotherapy will be given for a total of about 6 months. For patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.
Enrollment
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Inclusion criteria
Exclusion criteria
Pregnant patient;
History of psychiatric disease;
Use of systemic steroids;
Simultaneous multiple primary colorectal cancer;
Preoperative imaging examination results show:
Postoperative pathology of T1-T2 N0;
History of any other malignant tumor in recent 5 years;
Patients need emergency operation: mechanic ileus, perforation.
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups
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Central trial contact
Yueming Sun, PhD
Data sourced from clinicaltrials.gov
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