Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

A Randomized Controlled Clinical Trial to Investigate the Effect of Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

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

Study Overview

• Status: Unknown
• Conditions: Colon Cancer
• Intervention / Treatment: Drug: Postoperative chemotherapy; Drug: Neoadjuvant chemotherapy

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Postoperative chemotherapy; Patients receive 6 months of chemotherapy after surgery.	Drug: Postoperative chemotherapy; Locally advanced colon cancer patients will receive surgery first, followed by 6 months of chemotherapy. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.; Other Names: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy
Experimental: Neoadjuvant chemotherapy; Patients receive 3-4 cycles of chemotherapy before surgery. Preoperative and postoperative chemotherapy will be given for a total of 6 months.	Drug: Neoadjuvant chemotherapy; Neoadjuvant chemotherapy will be given to locally advanced colon cancer patients for 3-4 cycles. Surgery will be performed between 3 to 4 weeks subsequent to the last cycle of chemotherapy. After surgery, additional chemotherapy will be given. Preoperative and postoperative chemotherapy will be given for a total of 6 months. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.; Other Names: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time		1 day
number of lymph nodes retrieved		1 day
overall survival		3 years
local recurrence rate		3 years
recurrence-free survival		3 years
length of postoperative hospital stay	Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.	30 days
early complication rate	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.	30 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 28, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; locally advanced colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: CRSYM201608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No