A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant
chemotherapy with postoperative chemotherapy in patients with resectable locally advanced
Drug: Postoperative chemotherapy
Drug: Neoadjuvant chemotherapy
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Full eligibility criteria for NCT02882269
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients suitable for curative surgery between 18 to 80 years old;
American Society of Anesthesiologists(ASA) grade I-III;
Pathological diagnosis of adenocarcinoma;
Tumor located between the cecum and sigmoid colon;
Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
No preoperative chemoradiotherapy;
No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
History of psychiatric disease;
Use of systemic steroids;
Simultaneous multiple primary colorectal cancer;
Preoperative imaging examination results show:
unable to perform R0 resection;
Postoperative pathology of T1-T2 N0;
History of any other malignant tumor in recent 5 years;
Patients need emergency operation: mechanic ileus, perforation.
All locations for NCT02882269
View full eligibility
Tris trial is registered with FDA with number: NCT02882269. The sponsor of the trial is The First Affiliated Hospital with Nanjing Medical University and it is looking for 400 volunteers for the current phase.
Official trial title: A Randomized Controlled Clinical Trial to Investigate the Effect of Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer
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