Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

Phase 2

• Conditions: Colon Cancer
• Interventions: Drug: Postoperative chemotherapy; Drug: Neoadjuvant chemotherapy

• Registration Number: NCT02882269
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-28
• Study First Posted: 2016-08-29
• Last Update Posted: 2016-08-30
• Study Start: 2016-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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;
• Informed consent;
• No preoperative chemoradiotherapy;
• No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria

• Pregnant patient;

• History of psychiatric disease;

• Use of systemic steroids;

• Simultaneous multiple primary colorectal cancer;

• Preoperative imaging examination results show:

  1. distant metastasis;
  2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postoperative chemotherapy	Postoperative chemotherapy	Patients receive 6 months of chemotherapy after surgery.
Neoadjuvant chemotherapy	Neoadjuvant chemotherapy	Patients receive 3-4 cycles of chemotherapy before surgery. Preoperative and postoperative chemotherapy will be given for a total of 6 months.

Primary Outcome Measures

Name	Time	Method
disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years
recurrence-free survival	3 years
local recurrence rate	3 years
length of postoperative hospital stay	30 days	Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.
early complication rate	30 days	Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day 30. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.
operative time	1 day
number of lymph nodes retrieved	1 day