Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial

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 Overview

• Status: Active, not recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Drug: Neoadjuvant FOLFOX; Drug: Conventional adjuvant FOLFOX

• Study Type: Interventional
• Enrollment (Estimated): 708
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Korea
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Suwon, South Korea
    • The Catholic Univ. of Korea St. Vincent's Hospital
  • Chonnam
    • Hwasun, Chonnam, South Korea, 58128
      • Chonnam National University Hwasun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologically confirmed colon adenocarcinoma (> 15 cm from the anal verge)
• Radiologic T3/T4 and high risk features by CT scan
• No metastasis on CT or PET(positron emission computed tomography)
• Age ≥ 18 and ≤ 70 years
• ECOG (Eastern Cooperative Oncology Group) performance status 0-1
• No history of colorectal cancer within 5 years
• No history of chemotherapy
• Patients with childbearing potential should use effective contraception during the study and the following 6 months
• Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more
• Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less
• Adequate renal function : GFR (Glomerular Filtration Rate) > 50ml/min by Wright or Cockcroft formula
• Signed written informed consent obtained prior to any study specific screening procedures

Exclusion Criteria:

• Age > 70 years and < 18 years
• Rectal cancer : 15 cm or less from the anal verge
• Complicated colon cancer (complete obstruction, perforation, bleeding)
• Metastatic colon cancer
• Known hypersensitivity reaction to any of the components of study treatments
• Inflammatory bowel disease
• Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
• Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
• Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Pregnancy or breast-feeding period
• Serious non-healing wound or bone fracture
• Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
• Any significant disease which, in the investigator's opinion, would exclude the patient from the study

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
Experimental: Neoadjuvant FOLFOX; 4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX	Drug: Neoadjuvant FOLFOX; 4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy
Active Comparator: Conventional adjuvant FOLFOX; surgery followed by 12 cycles of FOLFOX	Drug: Conventional adjuvant FOLFOX; 12 cycles of postoperative FOLFOX chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse free survival after randomization	3 years after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		3 year after randomization
Radiological assessment of response to neoadjuvant treatment		6 months after surgery
Pathological assessment of response to neoadjuvant treatment	Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue	1 months after surgery
Surgical complication		60 days after surgery
Length of hospital stay		60 days after surgery
Quality of life (EORTC QLQ-C30)	QLQ (quality of life questionnaire)	before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Quality of life (EORTC QLQ-C38)		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	1 year
Incidence of completion of chemotherapy		1 year
Accuracy of CT staging		1 year
Total cycles of perioperative chemotherapy		1 year
Pathological tumor stage	Colon cancer stage by AJCC 8th edition	1 month after surgery

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Study Director: Soo Yeun Park, MD, Kyungpook National University Chilgok Hospital; Principal Investigator: Gyu-Seog Choi, MD, PhD, Kyungpook National University Chilgok Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Estimated): December 28, 2028
• Study Completion (Estimated): December 28, 2031

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Micronutrients; Protective Agents; Antidotes; Vitamin B Complex; Vitamins; Oxaliplatin; Fluorouracil; Leucovorin
• Other Study ID Numbers: KNUHCRC006

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No